Senior Supplier Quality Engineer - Exton, PA

Support the biomedical group regarding engineering activities for the ongoing and evolving stability and predictability of the supply chain. Interface with internal and external stakeholders to qualify and maintain suppliers for all product lines using tools such as supplier and component qualifications, data analysis, statistical process control (SPC), CAPA, KPIs, review, and trending. Lead supplier product-related root cause analysis, process mapping, and impact assessments for change control. Conduct CMO/supplier audits and associated downstream actions to meet dsm-firmenich expectations. Provide subject matter expertise in supplier management, evolve internal systems, and lead the supplier quality engineering team.

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.

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 an 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 outcomes for each task assigned or self-generated.
• Lead auditor ISO 13485 certification required (practicing for a minimum 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.

Benefits

• Competitive compensation package with comprehensive health and welfare benefits.
• Annual incentive pay.
• Retirement savings plan.
• Health care coverage.
• Paid time off.
• Recognition programs.
• Broad range of other benefits.

All benefits and incentives are subject to eligibility requirements.

Pay

The salary range for this position is $115,000.00 - $125,000.00. Individual pay offered will be based on the applicant’s job-related skills, experience, relevant education or training, and primary work location.