Senior Supplier Quality Engineer - Exton, PA
About The Position
The Sr. Supplier Quality Engineer will support the biomedical group regarding engineering activities for the ongoing and evolving stability and predictability of the supply chain. Interfacing with internal and external stakeholders to appropriately qualify and maintain suppliers for all product lines. Expected tools to meet these requirements include supplier and component qualifications, data analysis, statistical process control (SPC), CAPA and KPI’s, review and trending. Supplier Quality is responsible for supplier product-related root cause analysis, process mapping and impact assessments for change control. Supplier Quality will lead in CMO/Supplier audits and associated downstream actions to meet dsm-firmenich expectations. As a senior member in the supplier quality engineering team, the senior supplier quality engineer is expected to provide subject matter expertise in supplier management, understand and evolve internal systems to efficiently meet requirements, interface with vendors of all sizes, and provide leadership to the supplier quality engineering team.
Requirements
- BS Degree in an Engineering discipline (Biomedical, Mechanical, Materials, etc.), Materials Science or equivalent undergraduate experience.
- 8-12 years of Quality Engineering or Supplier Management at a FDA-Regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry.
- Experience with animal tissue, collagen, resin/polymers ideal.
- Hands on experience with supplier and component qualification required.
- Well-developed interpersonal and teamwork skills to communicate and resolve product quality issues with R&D, Production, Engineering and other departments.
- Demonstrated ability to multi-task resulting in positive outcome for each task assigned or self-generated.
- Lead auditor ISO 13485 certification required (practicing for a min of 5 years); Six Sigma, ASQ QE or CQA Certification a plus.
- Experience with 21 CFR820 required.
- Proficient in MS Office software including Word, Excel, and Outlook.
- Experience in statistical analysis (Minitab, Excel).
- Understanding of GMP and standards.
Nice To Haves
- Six Sigma, ASQ QE or CQA Certification
Responsibilities
- Serve as primary quality contact with vendors of all sizes and complexities.
- Own and manage the supplier qualification process and Approved Supplier List.
- Develop, document, and implement QA Procedures.
- Analyze internal systems for improvement and drive the improvement efforts.
- Perform external audits of CMOs/suppliers to appropriate criteria, report findings, and develop and track actions as required.
- Establish and negotiate Quality Agreements with required supply chain partners.
- Analyze non-conforming materials and returned goods and recommend disposition and corrective actions
- Prepare, review, and approve technical reports and provide recommendations based on data rationale.
- Develop, lead, and review root causes for non-conformances and deviations.
- Review documentation for completeness and accuracy.
- Complete other tasks and projects as assigned by the Supplier Quality Engineering Manager.
- Lead focused, multidisciplinary teams with clear objectives.
- Serve as leader, teacher, and mentor to other supplier quality team members.
- Work occasionally in a clean room setting following protective procedural requirements and comply with all safety requirements, including posted placards, SOPs and the Safety Manual.
- Adhere to Quality System procedures, ISO13485, 21CFR part 820 and current regulatory standards.
Benefits
- A competitive compensation package, with comprehensive health and welfare benefits
- A place to grow and develop.
- The opportunity to work on growing brands and build on a strong foundation.
- The chance to make improvements and make an impact on the business.
- annual incentive pay
- a retirement savings plan
- health care coverage
- paid time off
- recognition programs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
