Associate Director Device Quality Assurance
Listed on 2026-08-30
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
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 s role will serve as the primary interface between our Research & Development DQ&R and our Company's Wilson, NC site for the following aspects:
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)
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:
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and…
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).