Associate Director, Device QA & Regulatory (On-site)

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement plan (401(k))

Paid holidays and vacation

Hybrid work arrangement

Job summary

Merck & Co., Inc. in Wilson, NC is seeking an Associate Director of Device Quality Assurance to provide on-site quality oversight for medical device and combination product operations.

The role interfaces with R&D DQ&R and coordinates CAPA, changes, and audit support at the Wilson site. The candidate will bring 5+ years of QA experience in medical devices, strong communication and cross-functional collaboration skills, and a track record of driving quality improvements in a matrix organization.

Qualifications

• 5+ years of experience in quality assurance in a medical device or medical device combination product manufacturing organization.
• Bachelor’s degree in a 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

Responsibilities

• Provide on-site quality oversight for device assembly and packaging operations.
• Coordinate CAPA and deviation investigations impacting assembly/packaging.
• Interface with R&D DQ&R and site for risk assessments and changes.
• Support audits and regulatory interactions.
• Promote a culture of proactive issue surfacing and resolution for patient safety and product quality

Skills

Quality assurance

Communication

Cross-functional collaboration

Problem solving

Patient safety focus

Education

Bachelor's degree

Tools

ERP systems

Job description

Merck & Co., Inc. in Wilson, NC is seeking an Associate Director of Device Quality Assurance to provide on-site quality oversight for medical device and combination product operations.

The role interfaces with R&D DQ&R and coordinates CAPA, changes, and audit support at the Wilson site. The candidate will bring 5+ years of QA experience in medical devices, strong communication and cross-functional collaboration skills, and a track record of driving quality improvements in a matrix organization.