Summary:

Will provide cross-divisional support for remediation efforts. Under broad supervision, responsible for independently setting and upholding quality standards for portfolio of medical device, commodity, OTC drug, and/or cosmetic products. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR's, product specifications, design control files, and CE technical files.



Roles & Responsibilities:

• Provide Quality expertise in Product Development, Design Control activities, Design History Files, CAPA, Risk Management, and CE Technical Files.


• Direct and collaborate with supplier representatives on quality problems, ensure corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs. Lead supplier qualifications.


• Lead investigations of product and process non-conformances and o...