Stryker Leibinger GmbH & Co. KG
Senior Qualitätsingenieur Quality Assurance(m/w/x)
Full-timeTemporary contractWith HomeofficeSenior
Freiburg im Breisgau
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STStryker Leibinger GmbH & Co. KG
Quality Engineer/Senior Quality Engineer Post Market Surveillance(m/w/x)
Freiburg im Breisgau
Full-timeWith Home OfficeSenior
Nejo AI Summary
MDR creation and complaint assessment for resorbable implants, managing commercial holds and recalls at a specialized manufacturer. Knowledge in regulatory pathways, risk-benefit analysis, and post-marketing surveillance required; English and German skills essential. Entry-level friendly, career changers welcome.
Requirements
- Bachelor’s degree or equivalent in Engineering, Science, or related field
- 0+ years of experience in medical technology, pharmaceutical industry, or regulated environment
- Demonstrated knowledge in regulatory pathways, risk-benefit analysis, submission, registration, documentation, compliance, post-marketing surveillance, and distribution
- Strong technical writing, coordination, execution, communication, collaboration, and autonomous decision-making skills
- English and German language skills for global collaboration
Tasks
- Create and submit MDRs in compliance with FDA CFR 21, part 803
- Review and assess incoming product complaints for reportability
- Collaborate with clinicians and Post Market Functions for reportability decisions
- Compose rationale for events not meeting reporting criteria
- Manage commercial holds and assess need for Recalls/FSCAs
- Prepare and coordinate Recalls/FSCAs in line with regulatory requirements
- Maintain communication with Marketing, Production, Sales, and other functions
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Benefits
Flexible Working
- Flexible working hours
- Hybrid work model
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Stryker Leibinger GmbH & Co. KG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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STStryker Leibinger GmbH & Co. KG
Quality Engineer/Senior Quality Engineer Post Market Surveillance(m/w/x)
Freiburg im Breisgau
Full-timeWith Home OfficeSenior
Nejo AI Summary
MDR creation and complaint assessment for resorbable implants, managing commercial holds and recalls at a specialized manufacturer. Knowledge in regulatory pathways, risk-benefit analysis, and post-marketing surveillance required; English and German skills essential. Entry-level friendly, career changers welcome.
Requirements
- Bachelor’s degree or equivalent in Engineering, Science, or related field
- 0+ years of experience in medical technology, pharmaceutical industry, or regulated environment
- Demonstrated knowledge in regulatory pathways, risk-benefit analysis, submission, registration, documentation, compliance, post-marketing surveillance, and distribution
- Strong technical writing, coordination, execution, communication, collaboration, and autonomous decision-making skills
- English and German language skills for global collaboration
Tasks
- Create and submit MDRs in compliance with FDA CFR 21, part 803
- Review and assess incoming product complaints for reportability
- Collaborate with clinicians and Post Market Functions for reportability decisions
- Compose rationale for events not meeting reporting criteria
- Manage commercial holds and assess need for Recalls/FSCAs
- Prepare and coordinate Recalls/FSCAs in line with regulatory requirements
- Maintain communication with Marketing, Production, Sales, and other functions
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Benefits
Flexible Working
- Flexible working hours
- Hybrid work model
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Stryker Leibinger GmbH & Co. KG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Stryker Leibinger GmbH & Co. KG
Industry
Healthcare
Description
Das Unternehmen ist auf die Herstellung von resorbierbaren Implantaten in der Medizintechnik spezialisiert.
Not a perfect match?
- Stryker Leibinger GmbH & Co. KG
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