Senior Device Quality Lead - On-Site Oversight & Validation

Merck & Co.; Wilson (NC); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical, dental, vision benefits

401(k) retirement plan

Paid holidays and vacation

Job summary

Merck & Co., Inc. in Wilson, NC is seeking an Associate Director of Device Quality Assurance to oversee on-site quality for device assembly and packaging operations. The role interfaces with R&D DQ&R and site operations to ensure patient safety and product quality.

The position requires 5+ years in medical device QA, a science degree, strong problem-solving, and excellent communication. Hybrid work with a focus on cross-functional collaboration and audits.

Qualifications

• 5+ years experience in quality assurance for medical devices or combination products.
• Bachelor's degree in a relevant scientific discipline.
• Strong technical and innovative problem-solving skills.
• Excellent verbal and written communication, creativity, and interpersonal skills.
• Ability to partner and collaborate in a matrix organization.

Responsibilities

• Provide on-site quality oversight for device assembly and packaging operations at Wilson, NC site.
• Coordinate design transfers and device quality/regulatory support for processes impacting assembly.
• Lead CAPA activities and risk assessments; escalate issues with cross-site impact.
• Represent Device Quality & Regulatory in internal and external audits.

Skills

QA experience

Regulatory knowledge

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in science

Job description

Merck & Co., Inc. in Wilson, NC is seeking an Associate Director of Device Quality Assurance to oversee on-site quality for device assembly and packaging operations. The role interfaces with R&D DQ&R and site operations to ensure patient safety and product quality.

The position requires 5+ years in medical device QA, a science degree, strong problem-solving, and excellent communication. Hybrid work with a focus on cross-functional collaboration and audits.