Sr Supplier Qual Engineer
8200 Coral Sea Street Northeast New Brighton, MN 55112 US
Job Description
This role of pre-market Supplier Quality Engineering will directly be the key partner for selected development projects up to product launch.
- Can you please confirm your top 3 skills sets required?
- Supplier Management and Supplier Controls knowledge to develop supplier controls and qualification plans and reports to assure components, materials and suppliers meet specified requirements and performance, reliability goals.
- High Technical Rigor, review and approve changes to compnay specifications and review and approve supplier changes.
- Develop technical solutions to complex problems using the corrective/preventative action.
- Can you please confirm the 3 main responsibilities/day to day activities required for this role?
- Support the evaluation and selection of global best-in-class components suppliers/ CM/OEM through the application of appropriate tools and measurements
- Partner with multiple functions, including Supplier Quality, Design Engineering, Manufacturing, Quality, Reliability and Regulatory to evaluate, select and approve component or materials for active projects.
- Partner with suppliers to ensure components / materials / sub-assemblies are qualified and validated to the appropriate requirements prior to commercialization.
What products (if any) will this role support? As pre-market supplier quality, this role will support the New development process as SQE key partner. Will own different projects from early development phase up to post market transition. The support is across the CRM sites and/or Contract manufacturers.
- What is your target years of experience? 4+ years of experience in quality or engineering, Nice to Have: 4+ years of supplier quality engineering experience in the medical device industry or related field with supplier quality management expertise.
Would be essential to have knowledge of supplier controls, process validation, supplier and internal auditing, failure investigation techniques, statistical quality control, protocol/report preparation and non-conforming product controls Manufacturing processes or R&D experience.
Some of this main responsibilities may include but not limited to the following:
- Review and approve changes to company specifications for purchased materials
- Develop and maintain controls and qualification plans and reports
- Review and approve supplier change requests and partner with Sourcing Engineering to develop and implement appropriate strategies to qualify and support the change approval process
- Develop technical solutions to complex problems using the corrective/preventative action process
- Analyze and identify trends from quality data
- Lead or participate in supplier audit/assessment of current or future suppliers
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