Associate Director Device Quality Assurance

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

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 at Wilson. This role will serve as the primary interface between our Research & Development DQ&R and our Company's Wilson, NC site for the following aspects:

• 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.

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

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

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.

Requirements

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 skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

The salary range for this role is

$142,400.00 - $224,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

No Travel Required

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

09/13/2026

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R413851