Associate Director, Device Quality Assurance - Hybrid
About The Position
The Associate Director, Device Quality Assurance within Device Quality & Regulatory (DQ&R) is responsible for providing quality oversight of our Company's Device Network. This specific role is responsible for providing quality support for device assembly and packaging operations at our Company's Wilson, NC site and will be based on-site at Wilson. This role will serve as the primary interface between our Research & Development Division DQ&R and our Company's Wilson, NC site for the following aspects: 1. Serve as on-site quality oversight for medical device and combination product operations which require above-site support: Accountable for on-site Device Quality and Regulatory support for design transfer of combination products including method transfers to Wilson. Provides on-site Device Quality and Regulatory support for device assembly and packaging qualification and validation activities such as IQ/OQ/PQ and PPQ at Wilson. Accountable for coordinating Device Quality and Regulatory triage and root cause investigation of deviations impacting device assembly and packaging operations. Accountable for coordinating Device Quality and Regulatory evaluation of changes to processes which impact device assembly and packaging operations. Provides oversight of CAPA for device assembly and packaging operations including CAPA approval, performance of effectiveness checks and CAPA metric monitoring. Identifies issues with potential global and cross-site impact and escalates to global organizations. Accountable for providing Device Quality and Regulatory input to Quality Risk Assessments and risk management revisions (task 140). 2. Builds strong partnerships with site Operations, Packaging Technical Operations, Validation, Global DQ&R, and other functions to ensure seamless execution of device quality activities. 3. Promote a culture where issues are surfaced early, discussed openly, and resolved effectively, with a focus on patient safety and product quality. 4. Represents Device Quality and Regulatory for device related internal and external audits.
Requirements
- Bachelor's degree in relevant discipline
- 5 years of relevant experience in quality assurance in a medical device or medical device combination product manufacturing organization
- Strong technical and innovative problem solving skills
- Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills
- Demonstrated ability to partner and collaborate with cross-functional personnel and experience operating in a matrix organization
- Familiarity with device design verification and design control aspects
- Strong knowledge of device assembly and packaging operations
- Adaptability
- Change Management
- Combination Products
- Cross-Cultural Awareness
- Cross-Functional Teamwork
- GMP Training
- Good Distribution Practice (GDP)
- Inspection Readiness
- Leadership
- Manufacturing Quality Control
- Medical Device Quality Systems
- Medical Devices
- Package Management
- Packaging
- Packaging Processes
- Patient Safety
- Quality Assurance (QA)
- Quality Assurance (QA) Standards
- Quality Auditing
- Quality Management Standards
- Quality Metrics
- Quality Risk Assessment
- Quality Systems Compliance
- Regulatory Compliance
- Risk Management
Responsibilities
- Serve as on-site quality oversight for medical device and combination product operations which require above-site support
- Accountable for on-site Device Quality and Regulatory support for design transfer of combination products including method transfers to Wilson
- Provides on-site Device Quality and Regulatory support for device assembly and packaging qualification and validation activities such as IQ/OQ/PQ and PPQ at Wilson
- Accountable for coordinating Device Quality and Regulatory triage and root cause investigation of deviations impacting device assembly and packaging operations
- Accountable for coordinating Device Quality and Regulatory evaluation of changes to processes which impact device assembly and packaging operations
- Provides oversight of CAPA for device assembly and packaging operations including CAPA approval, performance of effectiveness checks and CAPA metric monitoring
- Identifies issues with potential global and cross-site impact and escalates to global organizations
- Accountable for providing Device Quality and Regulatory input to Quality Risk Assessments and risk management revisions (task 140)
- Builds strong partnerships with site Operations, Packaging Technical Operations, Validation, Global DQ&R, and other functions to ensure seamless execution of device quality activities
- Promote a culture where issues are surfaced early, discussed openly, and resolved effectively, with a focus on patient safety and product quality
- Represents Device Quality and Regulatory for device related internal and external audits
Benefits
- medical
- dental
- vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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What This Job Offers
Job Type
Full-time
Career Level
Director
