Associate Director, Device QA & Compliance

Merck; Wilson (NC); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck & Co., Inc. in Wilson, NC seeks an Associate Director of Device Quality Assurance to oversee on-site device operations, provide regulatory input, and drive CAPA and change-management processes.

The role interfaces with R&D DQ&R and site teams to ensure patient safety and product quality across assembly and packaging operations. The role emphasizes cross-functional partnership, adherence to GMP and design control, and continuous improvement, with an on-site, hybrid approach and

Qualifications

• 5+ years QA experience in medical device/combination product manufacturing.
• Bachelor’s degree in relevant scientific discipline.
• Strong technical and innovative problem-solving skills.
• Excellent verbal and written communication and collaboration skills.

Responsibilities

• Provide on-site quality oversight for medical device operations at Wilson.
• Coordinate quality/regulatory support for design transfer to Wilson.
• Support qualification/validation activities IQ/OQ/PQ/PPQ at Wilson.
• Coordinate CAPA for packaging operations and monitor effectiveness.
• Escalate issues with global impact to global teams.

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

Education

Bachelor’s degree in relevant scientific discipline

Job description

Merck & Co., Inc. in Wilson, NC seeks an Associate Director of Device Quality Assurance to oversee on-site device operations, provide regulatory input, and drive CAPA and change-management processes.

The role interfaces with R&D DQ&R and site teams to ensure patient safety and product quality across assembly and packaging operations. The role emphasizes cross-functional partnership, adherence to GMP and design control, and continuous improvement, with an on-site, hybrid approach and