
Senior Quality Assurance Specialist
5 days ago
Role Summary
We are seeking a skilled Senior Manufacturing Quality Engineer to join our international quality operations team. In this role, you will be responsible for ensuring the highest standards of quality in our manufacturing processes.
Responsibilities:
- Liaise with contract manufacturers and represent the company's quality interests.
- Generate, analyze, and report quality metrics to relevant personnel.
- Develop and implement on-going improvement programs.
- Lead cross-functional teams providing quality guidance and support.
- Perform rework process and ensure relevant documentation is prepared, reviewed, and approved.
- Conduct Acceptable Quality Level (AQL) inspections prior to product disposition.
- Execute stop ship process for finished products released to the market.
- Perform CAPA activities and document in the CAPA system if required.
- Review and approve documentation change controls, CCFs, and ECCs.
Requirements:
- Minimum 10 years of experience in manufacturing quality in medical devices or pharmaceutical industry or biochemistry production in a highly regulated environment.
- Bachelor's degree in Biochemistry or equivalent.
- Excellent organizational and communication skills.
- Fluent in English language.
- Solid working knowledge of EU, FDA, and related regulations including QSRs, FDA 21 CFR 820, ISO 13485, or ISO 9001, IVDs.
Nice to Have:
- Experience in quality management methods, 8D, Six Sigma, Statistical Tools, FMEA.
- Experience in working within multi-functional, multi-regional teams.
What We Offer:
This position offers a unique opportunity to work in an international quality operations team, contributing to the development of a world-class quality organization. You will have the chance to build a meaningful career, be creative, and try new things with the support you need to be successful.
Join our winning team today and accelerate the real-life impact of tomorrow's science and technology
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