This position ensures that the quality related engineering needs of the organization are met. Responsibilities include compliance and risk analysis, process validation, pFEMA’s, IQ, OQ, PQ and PPQ validation, CAPA and etc. Position works in collaboration with operations, supply chain, and new product development teams.

Position Description/Responsibilities:

• Lead in supporting compliance for medical device manufacturer in ID/Traceability throughout supply chain, well documented and executed Acceptance Activities, Non-conforming material management, Packaging/Labeling control, Production/Process controls, Process Validation.
• Risk Assessments, project meetings, pilot builds, First Article Inspections, and Post Market Risk Management
• Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
• Design and execution of pFEMA’s, IQ, OQ, PQ and PPQ validation
• Corrective and Preventive Action management, facilitation, ownership and problem resolution
• Process improvement and support, including Quality System process review and revision.
• Training assistance, including providing training in quality system activities/requirements
• Internal and external audit coordination and facilitation

Requirements:

• A Bachelor's degree in science, engineering or equivalent
• 10 or more year’s relevant experience
• At least 5 years’ experience in medical device manufacturing
• Strong knowledge of Quality Systems policies and regulations (ISO 13485 and FDA Part 820) with a strong background in medical device quality assurance and processes
• Experience conducting supplier audits and writing supplier contracts.
• Familiarity with statistical analysis.