Associate Director Device Quality Assurance

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:

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.

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:

Preferred Skills:

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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:

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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.

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The salary range for this role is

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.

You can apply for this role through https://jobs.merck.com/us/en (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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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Hazardous Material(s):

Job Posting End Date:

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Requisition ID:R413851