Beschreibung
The Client offers an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials.
Supplier Quality Engineer 100 % (m/f)
This position is fully dedicated to the transformation/restructuring project.
- Provide overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Client products.
- Provide complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes.
- Utilize multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), and international organization for standardization (ISO).
- Report on contract manufacturer performance metrics.
- Handle complex technical issues for manufacturing processes that are to be transferred to satellite facilities.
- Provide Quality Engineering support to suppliers including audits/assessments, inspection technique support, verification/validation activities, CAPA and change management.
Requirements:
- A minimum of a Bachelor's degree is required, preferably in an Engineering, Life Science, or related discipline.
- A minimum of 6years of experience in a highly regulated industry is required.
- Experience in the Medical Device industry and/or Pharmaceutical industry is required.
- FDA and ISO regulations knowledge is required, with FDA CFR Part 820 and ISO 13485 knowledge required.
- Auditing background is an asset.
- Blueprint literacy including GD&T is preferred.
- Experience in root cause analysis is required.
- Experience or knowledge with machining manufacturing processes and injection molding an asset.
- Six Sigma, Lean, or ASQ Certification and trainings an asset.
- This position may require up to 25% travel with occasional international
- Do you have a minimum of 6 years of experience in a highly regulated industry? (i.e. medical device, pharma, aerospace, automotive) - REQUIRED
- Do you have knowledge of FDA and ISO regulations? - REQUIRED
Please select all that apply to your experience and/or background:
- A degree in Engineering, Life Science or related discipline - ASSET
- Experience in Medical Device and/or Pharmaceutical industry - REQUIRED
- Knowledge of FDA CFR Part 820 and ISO 13485 - REQUIRED
- Auditing background - ASSET
- Experience in root cause analysis - REQUIRED
- Experience or knowledge with machining manufacturing processes and injection molding - ASSET
- Six Sigma, Lean, or ASQ Certification and trainings - ASSET
- Blueprint literacy including GD&T - ASSET