Kvalitetstekniker - Lediga jobb

Academic Resource söker nu en Kvalitetsansvarig / Quality Manager till ett företag i Stockholm.

Tjänsten är ett konsultuppdrag med start enligt överenskommelse.

Arbetet är under de första 2 månaderna på heltid, sedan jobbar man deltid enligt överenskommelse med kund.

Placering i Stockholm.

Om företaget:

Företagets produktportfölj omfattar kosttillskott och livsmedel för speciella medicinska ändamål (FSMP). Företaget arbetar internationellt med höga krav på kvalitet, patientsäkerhet och regelefterlevnad.

Om rollen:

Som kvalitetsansvarig ansvarar du för företagets kvalitetsledningssystem (QMS) och säkerställer att verksamheten uppfyller gällande kvalitets- och regulatoriska krav. Rollen kombinerar strategiskt ansvar med operativt arbete och innebär många kontaktytor, både internt och externt.

Arbetsuppgifter:

• Ansvara för och vidareutveckla företagets kvalitetsledningssystem (QMS).

• Säkerställa att kvalitetsrutiner, SOP och dokumentation är uppdaterade.

• Följa och implementera gällande regelverk för kosttillskott och FSMP.

• Hantera kvalitetsfrågor gentemot tillverkare, leverantörer, distributörer och kunder.

• Ansvara för reklamationshantering och utredning av kvalitetsavvikelser.

• Planera och stödja interna och externa revisioner samt leverantörsbedömningar.

• Säkerställa spårbarhet, granska produktdokumentation och märkning.

• Utbilda organisationen inom kvalitet och regelefterlevnad.

• Samarbeta nära VD och externa partners i kvalitets- och regulatoriska frågor.

Kvalifikationer:

• Akademisk examen inom exempelvis livsmedelsvetenskap, farmaci, nutrition, biovetenskap eller motsvarande.

• Minst två års erfarenhet av kvalitetsarbete inom livsmedel, kosttillskott, medicinsk nutrition, läkemedel eller annan reglerad verksamhet.

• Erfarenhet av revisioner och regulatorisk efterlevnad.

• Mycket goda kunskaper i engelska, både i tal och skrift.

Meriterande:

• Erfarenhet av HACCP, GMP, ISO 9001 eller liknande kvalitetsstandarder.

• Erfarenhet av internationella leverantörer och kontraktstillverkning.

• Kunskap om produkter inom medicinsk nutrition eller FSMP.

Vi söker dig som är:

• Strukturerad, noggrann och kvalitetsmedveten.

• Analytisk och lösningsorienterad.

• Självständig med god samarbetsförmåga.

• Kommunikativ och van att arbeta med många kontaktytor.

Du rapporterar direkt till VD och har en central roll i företagets fortsatta kvalitets- och regulatoriska arbete.

Om Academic Resource:

Academic Resource är rekryterings- och bemanningsföretaget för akademiker med erfarenhet.

Vi har lång erfarenhet av Uthyrning, Rekrytering samt Interim Management inom tjänstesektorn.

Våra affärsområden är Life Science, Ekonomi & Finans, samt HR. Vi verkar inom tjänstesektorn och främst i Stockholm & Uppsala.

Som konsult hos Academic Resource erbjuds du:

• Förmåner som t.ex. tjänstepension, friskvårdsbidrag och föräldralön.

• Ett auktoriserat bemanningsföretag vilket innebär en mycket större trygghet, då du omfattas av kollektivavtalens villkor för till exempel lön, försäkringar, pension och semester.

• En engagerad konsultchef som finns tillgänglig och håller löpande kontakt med dig och kundföretagen under hela din anställning som ser till att du trivs och utvecklas på din arbetsplats!

• Möjlighet att utvecklas genom lärande på arbete såväl som i varierade roller på intressanta kundföretag.

Ansökan:

Intervjuer och urval sker löpande, så ansök gärna så snart som möjligt.

Skicka in ditt CV och personliga brev i PDF eller Word format.

Klicka på Sök tjänsten och ange referens: NKA0726

Vid frågor är du välkommen att kontakta:

rekrytering.lifescience@academicresource.se

Observera att vi inte tar emot ansökningar via e-post.

We take you further!

Are you passionate about quality, contamination control, and medical device manufacturing? We are looking for a Cleanliness & Sterility Assurance Engineer to join our team and support the cleanliness and sterility assurance of dental implant products manufactured at our sites in Karlskoga, Sweden, and Yorba Linda, USA.

In this role, you will play a key part in ensuring compliance with regulatory requirements and industry standards while contributing to the safety and quality of products that improve patients' lives worldwide.

Key Responsibilities

As a Cleanliness & Sterility Assurance Engineer, you will:

• Define validation studies related to microbiological, physical, and chemical cleanliness for new equipment and equipment modifications.
• Lead and execute cleanliness process validations for new and updated manufacturing equipment.
• Develop and implement cleanliness monitoring activities in collaboration with the Contamination Control Manager.
• Maintain and update contact material mapping documentation.
• Establish and maintain procedures, templates, and best practices to ensure standardized cleanliness validation and monitoring processes.
• Support biological and microbiological safety strategies across the organization.
• Coordinate and manage external testing activities with approved laboratories and vendors when required.
• Collaborate with cross-functional teams to support continuous improvement and regulatory compliance initiatives.

Qualifications and Experience

To succeed in this role, you should have:

• A Master's degree (MSc) or equivalent in Biotechnology, Biomedical Engineering, Microbiology, Toxicology, Biology, Chemistry, or another relevant scientific discipline.
• At least 5 years of experience within the Medical Device industry or a comparable regulated environment.
• Strong knowledge of contamination control, cleanliness assurance, and applicable regulatory standards, or the ability to quickly develop expertise and work independently with limited supervision.
• Experience with relevant standards such as ISO 13485 and ISO 11137-1 & 2.
• A solid understanding of manufacturing processes and process validation methodologies.
• Strong expertise in statistical analysis and interpretation of technical data.
• Excellent communication skills, both written and verbal.
• Fluency in English. Swedish language skills are considered an advantage.
• A structured, analytical, and problem-solving mindset.

Are you passionate about quality, contamination control, and medical device manufacturing? We are looking for a Cleanliness & Sterility Assurance Engineer to join our team and support the cleanliness and sterility assurance of dental implant products manufactured at our sites in Karlskoga, Sweden, and Yorba Linda, USA.

In this role, you will play a key part in ensuring compliance with regulatory requirements and industry standards while contributing to the safety and quality of products that improve patients' lives worldwide.

Key Responsibilities

As a Cleanliness & Sterility Assurance Engineer, you will:

• Define validation studies related to microbiological, physical, and chemical cleanliness for new equipment and equipment modifications.
• Lead and execute cleanliness process validations for new and updated manufacturing equipment.
• Develop and implement cleanliness monitoring activities in collaboration with the Contamination Control Manager.
• Maintain and update contact material mapping documentation.
• Establish and maintain procedures, templates, and best practices to ensure standardized cleanliness validation and monitoring processes.
• Support biological and microbiological safety strategies across the organization.
• Coordinate and manage external testing activities with approved laboratories and vendors when required.
• Collaborate with cross-functional teams to support continuous improvement and regulatory compliance initiatives.

Qualifications and Experience

To succeed in this role, you should have:

• A Master's degree (MSc) or equivalent in Biotechnology, Biomedical Engineering, Microbiology, Toxicology, Biology, Chemistry, or another relevant scientific discipline.
• At least 5 years of experience within the Medical Device industry or a comparable regulated environment.
• Strong knowledge of contamination control, cleanliness assurance, and applicable regulatory standards, or the ability to quickly develop expertise and work independently with limited supervision.
• Experience with relevant standards such as ISO 13485 and ISO 11137-1 & 2.
• A solid understanding of manufacturing processes and process validation methodologies.
• Strong expertise in statistical analysis and interpretation of technical data.
• Excellent communication skills, both written and verbal.
• Fluency in English. Swedish language skills are considered an advantage.
• A structured, analytical, and problem-solving mindset.

Are you passionate about quality, contamination control, and medical device manufacturing? We are looking for a Cleanliness & Sterility Assurance Engineer to join our team and support the cleanliness and sterility assurance of dental implant products manufactured at our sites in Karlskoga, Sweden, and Yorba Linda, USA.

In this role, you will play a key part in ensuring compliance with regulatory requirements and industry standards while contributing to the safety and quality of products that improve patients' lives worldwide.

Key Responsibilities

As a Cleanliness & Sterility Assurance Engineer, you will:

• Define validation studies related to microbiological, physical, and chemical cleanliness for new equipment and equipment modifications.
• Lead and execute cleanliness process validations for new and updated manufacturing equipment.
• Develop and implement cleanliness monitoring activities in collaboration with the Contamination Control Manager.
• Maintain and update contact material mapping documentation.
• Establish and maintain procedures, templates, and best practices to ensure standardized cleanliness validation and monitoring processes.
• Support biological and microbiological safety strategies across the organization.
• Coordinate and manage external testing activities with approved laboratories and vendors when required.
• Collaborate with cross-functional teams to support continuous improvement and regulatory compliance initiatives.

Qualifications and Experience

To succeed in this role, you should have:

• A Master's degree (MSc) or equivalent in Biotechnology, Biomedical Engineering, Microbiology, Toxicology, Biology, Chemistry, or another relevant scientific discipline.
• At least 5 years of experience within the Medical Device industry or a comparable regulated environment.
• Strong knowledge of contamination control, cleanliness assurance, and applicable regulatory standards, or the ability to quickly develop expertise and work independently with limited supervision.
• Experience with relevant standards such as ISO 13485 and ISO 11137-1 & 2.
• A solid understanding of manufacturing processes and process validation methodologies.
• Strong expertise in statistical analysis and interpretation of technical data.
• Excellent communication skills, both written and verbal.
• Fluency in English. Swedish language skills are considered an advantage.
• A structured, analytical, and problem-solving mindset.

Are you passionate about quality, contamination control, and medical device manufacturing? We are looking for a Cleanliness & Sterility Assurance Engineer to join our team and support the cleanliness and sterility assurance of dental implant products manufactured at our sites in Karlskoga, Sweden, and Yorba Linda, USA.

In this role, you will play a key part in ensuring compliance with regulatory requirements and industry standards while contributing to the safety and quality of products that improve patients' lives worldwide.

Key Responsibilities

As a Cleanliness & Sterility Assurance Engineer, you will:

• Define validation studies related to microbiological, physical, and chemical cleanliness for new equipment and equipment modifications.
• Lead and execute cleanliness process validations for new and updated manufacturing equipment.
• Develop and implement cleanliness monitoring activities in collaboration with the Contamination Control Manager.
• Maintain and update contact material mapping documentation.
• Establish and maintain procedures, templates, and best practices to ensure standardized cleanliness validation and monitoring processes.
• Support biological and microbiological safety strategies across the organization.
• Coordinate and manage external testing activities with approved laboratories and vendors when required.
• Collaborate with cross-functional teams to support continuous improvement and regulatory compliance initiatives.

Qualifications and Experience

To succeed in this role, you should have:

• A Master's degree (MSc) or equivalent in Biotechnology, Biomedical Engineering, Microbiology, Toxicology, Biology, Chemistry, or another relevant scientific discipline.
• At least 5 years of experience within the Medical Device industry or a comparable regulated environment.
• Strong knowledge of contamination control, cleanliness assurance, and applicable regulatory standards, or the ability to quickly develop expertise and work independently with limited supervision.
• Experience with relevant standards such as ISO 13485 and ISO 11137-1 & 2.
• A solid understanding of manufacturing processes and process validation methodologies.
• Strong expertise in statistical analysis and interpretation of technical data.
• Excellent communication skills, both written and verbal.
• Fluency in English. Swedish language skills are considered an advantage.
• A structured, analytical, and problem-solving mindset.

Are you passionate about quality, contamination control, and medical device manufacturing? We are looking for a Cleanliness & Sterility Assurance Engineer to join our team and support the cleanliness and sterility assurance of dental implant products manufactured at our sites in Karlskoga, Sweden, and Yorba Linda, USA.

In this role, you will play a key part in ensuring compliance with regulatory requirements and industry standards while contributing to the safety and quality of products that improve patients' lives worldwide.

Key Responsibilities

As a Cleanliness & Sterility Assurance Engineer, you will:

• Define validation studies related to microbiological, physical, and chemical cleanliness for new equipment and equipment modifications.
• Lead and execute cleanliness process validations for new and updated manufacturing equipment.
• Develop and implement cleanliness monitoring activities in collaboration with the Contamination Control Manager.
• Maintain and update contact material mapping documentation.
• Establish and maintain procedures, templates, and best practices to ensure standardized cleanliness validation and monitoring processes.
• Support biological and microbiological safety strategies across the organization.
• Coordinate and manage external testing activities with approved laboratories and vendors when required.
• Collaborate with cross-functional teams to support continuous improvement and regulatory compliance initiatives.

Qualifications and Experience

To succeed in this role, you should have:

• A Master's degree (MSc) or equivalent in Biotechnology, Biomedical Engineering, Microbiology, Toxicology, Biology, Chemistry, or another relevant scientific discipline.
• At least 5 years of experience within the Medical Device industry or a comparable regulated environment.
• Strong knowledge of contamination control, cleanliness assurance, and applicable regulatory standards, or the ability to quickly develop expertise and work independently with limited supervision.
• Experience with relevant standards such as ISO 13485 and ISO 11137-1 & 2.
• A solid understanding of manufacturing processes and process validation methodologies.
• Strong expertise in statistical analysis and interpretation of technical data.
• Excellent communication skills, both written and verbal.
• Fluency in English. Swedish language skills are considered an advantage.
• A structured, analytical, and problem-solving mindset.

Are you passionate about quality, contamination control, and medical device manufacturing? We are looking for a Cleanliness & Sterility Assurance Engineer to join our team and support the cleanliness and sterility assurance of dental implant products manufactured at our sites in Karlskoga, Sweden, and Yorba Linda, USA.

In this role, you will play a key part in ensuring compliance with regulatory requirements and industry standards while contributing to the safety and quality of products that improve patients' lives worldwide.

Key Responsibilities

As a Cleanliness & Sterility Assurance Engineer, you will:

• Define validation studies related to microbiological, physical, and chemical cleanliness for new equipment and equipment modifications.
• Lead and execute cleanliness process validations for new and updated manufacturing equipment.
• Develop and implement cleanliness monitoring activities in collaboration with the Contamination Control Manager.
• Maintain and update contact material mapping documentation.
• Establish and maintain procedures, templates, and best practices to ensure standardized cleanliness validation and monitoring processes.
• Support biological and microbiological safety strategies across the organization.
• Coordinate and manage external testing activities with approved laboratories and vendors when required.
• Collaborate with cross-functional teams to support continuous improvement and regulatory compliance initiatives.

Qualifications and Experience

To succeed in this role, you should have:

• A Master's degree (MSc) or equivalent in Biotechnology, Biomedical Engineering, Microbiology, Toxicology, Biology, Chemistry, or another relevant scientific discipline.
• At least 5 years of experience within the Medical Device industry or a comparable regulated environment.
• Strong knowledge of contamination control, cleanliness assurance, and applicable regulatory standards, or the ability to quickly develop expertise and work independently with limited supervision.
• Experience with relevant standards such as ISO 13485 and ISO 11137-1 & 2.
• A solid understanding of manufacturing processes and process validation methodologies.
• Strong expertise in statistical analysis and interpretation of technical data.
• Excellent communication skills, both written and verbal.
• Fluency in English. Swedish language skills are considered an advantage.
• A structured, analytical, and problem-solving mindset.

Are you passionate about quality, contamination control, and medical device manufacturing? We are looking for a Cleanliness & Sterility Assurance Engineer to join our team and support the cleanliness and sterility assurance of dental implant products manufactured at our sites in Karlskoga, Sweden, and Yorba Linda, USA.

In this role, you will play a key part in ensuring compliance with regulatory requirements and industry standards while contributing to the safety and quality of products that improve patients' lives worldwide.

Key Responsibilities

As a Cleanliness & Sterility Assurance Engineer, you will:

• Define validation studies related to microbiological, physical, and chemical cleanliness for new equipment and equipment modifications.
• Lead and execute cleanliness process validations for new and updated manufacturing equipment.
• Develop and implement cleanliness monitoring activities in collaboration with the Contamination Control Manager.
• Maintain and update contact material mapping documentation.
• Establish and maintain procedures, templates, and best practices to ensure standardized cleanliness validation and monitoring processes.
• Support biological and microbiological safety strategies across the organization.
• Coordinate and manage external testing activities with approved laboratories and vendors when required.
• Collaborate with cross-functional teams to support continuous improvement and regulatory compliance initiatives.

Qualifications and Experience

To succeed in this role, you should have:

• A Master's degree (MSc) or equivalent in Biotechnology, Biomedical Engineering, Microbiology, Toxicology, Biology, Chemistry, or another relevant scientific discipline.
• At least 5 years of experience within the Medical Device industry or a comparable regulated environment.
• Strong knowledge of contamination control, cleanliness assurance, and applicable regulatory standards, or the ability to quickly develop expertise and work independently with limited supervision.
• Experience with relevant standards such as ISO 13485 and ISO 11137-1 & 2.
• A solid understanding of manufacturing processes and process validation methodologies.
• Strong expertise in statistical analysis and interpretation of technical data.
• Excellent communication skills, both written and verbal.
• Fluency in English. Swedish language skills are considered an advantage.
• A structured, analytical, and problem-solving mindset.

Are you passionate about quality, contamination control, and medical device manufacturing? We are looking for a Cleanliness & Sterility Assurance Engineer to join our team and support the cleanliness and sterility assurance of dental implant products manufactured at our sites in Karlskoga, Sweden, and Yorba Linda, USA.

In this role, you will play a key part in ensuring compliance with regulatory requirements and industry standards while contributing to the safety and quality of products that improve patients' lives worldwide.

Key Responsibilities

As a Cleanliness & Sterility Assurance Engineer, you will:

• Define validation studies related to microbiological, physical, and chemical cleanliness for new equipment and equipment modifications.
• Lead and execute cleanliness process validations for new and updated manufacturing equipment.
• Develop and implement cleanliness monitoring activities in collaboration with the Contamination Control Manager.
• Maintain and update contact material mapping documentation.
• Establish and maintain procedures, templates, and best practices to ensure standardized cleanliness validation and monitoring processes.
• Support biological and microbiological safety strategies across the organization.
• Coordinate and manage external testing activities with approved laboratories and vendors when required.
• Collaborate with cross-functional teams to support continuous improvement and regulatory compliance initiatives.

Qualifications and Experience

To succeed in this role, you should have:

• A Master's degree (MSc) or equivalent in Biotechnology, Biomedical Engineering, Microbiology, Toxicology, Biology, Chemistry, or another relevant scientific discipline.
• At least 5 years of experience within the Medical Device industry or a comparable regulated environment.
• Strong knowledge of contamination control, cleanliness assurance, and applicable regulatory standards, or the ability to quickly develop expertise and work independently with limited supervision.
• Experience with relevant standards such as ISO 13485 and ISO 11137-1 & 2.
• A solid understanding of manufacturing processes and process validation methodologies.
• Strong expertise in statistical analysis and interpretation of technical data.
• Excellent communication skills, both written and verbal.
• Fluency in English. Swedish language skills are considered an advantage.
• A structured, analytical, and problem-solving mindset.

Are you passionate about quality, contamination control, and medical device manufacturing? We are looking for a Cleanliness & Sterility Assurance Engineer to join our team and support the cleanliness and sterility assurance of dental implant products manufactured at our sites in Karlskoga, Sweden, and Yorba Linda, USA.

In this role, you will play a key part in ensuring compliance with regulatory requirements and industry standards while contributing to the safety and quality of products that improve patients' lives worldwide.

Key Responsibilities

As a Cleanliness & Sterility Assurance Engineer, you will:

• Define validation studies related to microbiological, physical, and chemical cleanliness for new equipment and equipment modifications.
• Lead and execute cleanliness process validations for new and updated manufacturing equipment.
• Develop and implement cleanliness monitoring activities in collaboration with the Contamination Control Manager.
• Maintain and update contact material mapping documentation.
• Establish and maintain procedures, templates, and best practices to ensure standardized cleanliness validation and monitoring processes.
• Support biological and microbiological safety strategies across the organization.
• Coordinate and manage external testing activities with approved laboratories and vendors when required.
• Collaborate with cross-functional teams to support continuous improvement and regulatory compliance initiatives.

Qualifications and Experience

To succeed in this role, you should have:

• A Master's degree (MSc) or equivalent in Biotechnology, Biomedical Engineering, Microbiology, Toxicology, Biology, Chemistry, or another relevant scientific discipline.
• At least 5 years of experience within the Medical Device industry or a comparable regulated environment.
• Strong knowledge of contamination control, cleanliness assurance, and applicable regulatory standards, or the ability to quickly develop expertise and work independently with limited supervision.
• Experience with relevant standards such as ISO 13485 and ISO 11137-1 & 2.
• A solid understanding of manufacturing processes and process validation methodologies.
• Strong expertise in statistical analysis and interpretation of technical data.
• Excellent communication skills, both written and verbal.
• Fluency in English. Swedish language skills are considered an advantage.
• A structured, analytical, and problem-solving mindset.