Associate Director, Device Quality Assurance - Hybrid

Merck•Wilson, NC

1d•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.