Quality Assurance Manager responsible for leadership in Quality Management Systems at a biotech company. Ensuring compliance, scalability, and driving culture of quality improvement.
About the role
- Senior Supplier Quality Engineer ensuring product quality and driving process improvements at suppliers. Collaborating across functions to maintain compliance with industry standards and regulations.
Responsibilities
- Act as Manufacturing Engineer and/product quality at Suppliers
- Proactively monitor and measure product/process quality and performance trends
- Troubleshoot production/release issues
- Develop, support, and drive equipment qualification and process validation plans
- Lead continuous improvement projects based on process/product trends, customer complaints, and regulations
- Provide Quality oversight of product/process change requests
Requirements
- 5+ years of experience in Supplier Quality
- Skills in technical innovation, technical leadership, mechanical and/or electrical engineering
- Understanding adherence to GMP practices and FDA regulations
- Knowledge and use of relevant PC software applications
- Bachelor’s degree or equivalent education and experience
- Experienced in DFMAT (Design for manufacturability and testability)
- Ability to apply DFMEA for Process Validation and Validation plan at suppliers
Benefits
- Comprehensive Philips Total Rewards benefits program
- Generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- Stock purchase plan
- Education reimbursement
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