Job Description
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 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.
Required Qualifications and Skills:
- 5 or more years relevant experience in quality assurance in a medical device or medical device combination product manufacturing organization.
- Bachelor’s degree in relevant scientific discipline
- 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
Preferred Qualifications and Skills:
- Familiarity with device design verification and design control aspects
- Strong knowledge of device assembly and packaging operations
eligibleforERP
Required Skills:
Adaptability, Change Management, Cross-Cultural Awareness, Cross-Functional Teamwork, GMP Training, Inspection Readiness, Manufacturing Quality Control, Medical Devices, Quality Auditing, Quality Management Standards, Quality Metrics, Quality Systems Compliance, Regulatory Compliance, Risk Management
Preferred Skills:
Current Employees apply
Current Contingent Workers apply
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
09/13/2026
*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
