Kvalitetstekniker - Lediga jobb

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.

Lyten Sweden is seeking a professional Quality Control Technician to join our R&D organization in Västerås. In this role you will be responsible for analysing materials, incoming parts, product intermediates and finalized products for R&D, production and external suppliers using a wide range of instruments. You will participates in problem solving, technical troubleshooting exercises and technical discussions where needed.

Key responsibilities (including but not limited to)

• Write the testing plans for materials, incoming parts, product intermediates and finalized products

• Perform testing of control plan inspection items using a variety of laboratory instruments

• Perform data analysis/interpretation and report according to quality standards

• Be able to troubleshoot first of line problems arising on the instruments

• Drive method improvements; help update standard operating procedures as needed

• Perform regular (daily, weekly, monthly) preventive maintenance on instruments

• Become familiar with the fundamentals of quality assurance and quality control principles and relevant quality management system requirements (control plan, non-conformity management, deviation and change management, control samples and control charts, calibration management, ISO9001, IATF16949, ISO17025, etc.)

• Adhere to and ensure 5S and safety protocols are maintained within the laboratory work environment

• Always work with safety as first priority

Requirements

Qualifications and experience

• Bachelor´s degree (or technical school degree) in Chemistry or a technical field is preferred.

• Significant relevant previous laboratory and work experience.

• Hands-on experience using a set of relevant analytical instruments and measurement equipment.

• Experience within a quality control work environment is a plus.

• Curious, technically educated, and with an interest in a laboratory career in industry.
• Knowledgeable in Lean and six sigma

• Familiar with SPC, FMEA, Quality troubleshooting tools and problem-solving methodology

Specific skills

• Excellent oral and written communication skills in English, Swedish is a plus

• User experience with Office and JIRA software

Lyten Sweden is seeking a professional Quality Control Technician to join our R&D organization in Västerås. In this role you will be responsible for analysing materials, incoming parts, product intermediates and finalized products for R&D, production and external suppliers using a wide range of instruments. You will participates in problem solving, technical troubleshooting exercises and technical discussions where needed.

Key responsibilities (including but not limited to)

• Write the testing plans for materials, incoming parts, product intermediates and finalized products

• Perform testing of control plan inspection items using a variety of laboratory instruments

• Perform data analysis/interpretation and report according to quality standards

• Be able to troubleshoot first of line problems arising on the instruments

• Drive method improvements; help update standard operating procedures as needed

• Perform regular (daily, weekly, monthly) preventive maintenance on instruments

• Become familiar with the fundamentals of quality assurance and quality control principles and relevant quality management system requirements (control plan, non-conformity management, deviation and change management, control samples and control charts, calibration management, ISO9001, IATF16949, ISO17025, etc.)

• Adhere to and ensure 5S and safety protocols are maintained within the laboratory work environment

• Always work with safety as first priority

Requirements

Qualifications and experience

• Bachelor´s degree (or technical school degree) in Chemistry or a technical field is preferred.

• Significant relevant previous laboratory and work experience.

• Hands-on experience using a set of relevant analytical instruments and measurement equipment.

• Experience within a quality control work environment is a plus.

• Curious, technically educated, and with an interest in a laboratory career in industry.
• Knowledgeable in Lean and six sigma

• Familiar with SPC, FMEA, Quality troubleshooting tools and problem-solving methodology

Specific skills

• Excellent oral and written communication skills in English, Swedish is a plus

• User experience with Office and JIRA software

Lyten Sweden is seeking a professional Quality Control Technician to join our R&D organization in Västerås. In this role you will be responsible for analysing materials, incoming parts, product intermediates and finalized products for R&D, production and external suppliers using a wide range of instruments. You will participates in problem solving, technical troubleshooting exercises and technical discussions where needed.

Key responsibilities (including but not limited to)

• Write the testing plans for materials, incoming parts, product intermediates and finalized products

• Perform testing of control plan inspection items using a variety of laboratory instruments

• Perform data analysis/interpretation and report according to quality standards

• Be able to troubleshoot first of line problems arising on the instruments

• Drive method improvements; help update standard operating procedures as needed

• Perform regular (daily, weekly, monthly) preventive maintenance on instruments

• Become familiar with the fundamentals of quality assurance and quality control principles and relevant quality management system requirements (control plan, non-conformity management, deviation and change management, control samples and control charts, calibration management, ISO9001, IATF16949, ISO17025, etc.)

• Adhere to and ensure 5S and safety protocols are maintained within the laboratory work environment

• Always work with safety as first priority

Requirements

Qualifications and experience

• Bachelor´s degree (or technical school degree) in Chemistry or a technical field is preferred.

• Significant relevant previous laboratory and work experience.

• Hands-on experience using a set of relevant analytical instruments and measurement equipment.

• Experience within a quality control work environment is a plus.

• Curious, technically educated, and with an interest in a laboratory career in industry.
• Knowledgeable in Lean and six sigma

• Familiar with SPC, FMEA, Quality troubleshooting tools and problem-solving methodology

Specific skills

• Excellent oral and written communication skills in English, Swedish is a plus

• User experience with Office and JIRA software