Associate Director Device Quality Assurance

Biopharma Careers; Kansas; On-site; USD 142,000 - 224,000; Full time

Job summary

Merck is seeking an Associate Director, Device Quality Assurance to provide quality oversight of our Device Quality & Regulatory network. The role is based on-site at the Wilson, NC site and serves as the primary interface between R&D DQ&R and the Wilson site, ensuring device assembly and packaging operations meet quality and regulatory standards.

Responsibilities include leading on-site QA for transfer activities, IQ/OQ/PQ and PPQ, CAPA coordination, risk assessments input, cross-functional

Qualifications

• 5+ years in quality assurance within a medical device or combination product manufacturing environment.
• Bachelor's degree in a scientific field.
• Strong problem-solving and communication skills.
• Ability to partner across functions in a matrix organization.

Responsibilities

• Provide on-site quality oversight for medical device and combination product operations at Wilson, NC.
• Coordinate design transfer and method transfers for combination products.
• Lead on-site QA for device assembly/packaging qualification and validation (IQ/OQ/PQ, PPQ).
• Coordinate CAPA activities and effectiveness checks for device assembly/packaging operations.
• Support risk assessments and regulatory input for changes affecting device operations.

Skills

Quality Assurance

GMP Training

Regulatory Compliance

Cross-functional Collaboration

Problem Solving

Education

Bachelor's degree

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
• eligibleforERP

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

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

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.

Learn more about your rights, including under California, Colorado and other US State Acts

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

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.