Associate Director, Device Quality Assurance - Hybrid

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 Division DQ&R and our Company's Wilson, NC site for the following aspects:

1. 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).

2. Builds strong partnerships with site Operations, Packaging Technical Operations, Validation, Global DQ&R, and other functions to ensure seamless execution of device quality activities.

3. Promote a culture where issues are surfaced early, discussed openly, and resolved effectively, with a focus on patient safety and product quality.

4. Represents Device Quality and Regulatory for device related internal and external audits.

Education Requirement:

• Bachelor's degree in relevant discipline.

Experience and Skills Required:

• 5 years of relevant experience in quality assurance in a medical device or medical device combination product manufacturing organization.
• 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.
• Familiarity with device design verification and design control aspects.
• Strong knowledge of device assembly and packaging operations.

Required Skills:
Adaptability, Change Management, Combination Products, Cross-Cultural Awareness, Cross-Functional Teamwork, GMP Training, Good Distribution Practice (GDP), Inspection Readiness, Leadership, Manufacturing Quality Control, Medical Device Quality Systems, Medical Devices, Package Management, Packaging, Packaging Processes, Patient Safety, Quality Assurance (QA), Quality Assurance (QA) Standards, Quality Auditing, Quality Management Standards, Quality Metrics, Quality Risk Assessment, Quality Systems Compliance, Regulatory Compliance, Risk Management

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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. Please click here if you need an accommodation during the application or hiring process.

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

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

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 .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:
25%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
No

Job Posting End Date:
04/24/2026
*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: R388524