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Associate Director, Medical Devices (Quality Systems Improvement Program)


Whitehouse Station West, NJ
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Job Details

Job Title: Associate Director, Medical Devices (Quality Systems Improvement Program)  - CLI005838

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.  Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.  To this end, we strive to create an environment of mutual respect, encouragement and teamwork.  As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Reporting to the Director,  Medical Device and Combination Product Quality (MDCPQ), responsible for independent support of compliance development and commercial of Medical Devices including the device constituent part of Combination Products.  This position will interact with cross functional teams working with all levels of employees.  Activities will include developing, documenting, and maintenance of technical business solutions or audits of data, information, procedures, and systems to ensure compliance with Medical Device and Combination Product Current Good Manufacturing Practices (CGMPs), other worldwide regulations and Merck requirements.  In addition, the MDCP Quality Associate Director is responsible for planning and program execution relating to MDCP projects.


Primary Responsibilities include:

  • Executing with development, safety and clinical groups Device Risk Management Files from initiations to obsolescence
  • Expert knowledge of ISO 14971:2012
  • Must have led teams in the development of Device Risk Management Files
  • Supports maintenance, knowledge transfer, and as needed development of Merck’s Device specific Quality Management System.
  • Participates on Merck teams supporting MDCP CGMP and quality issues related to pure medical devices and the device constituent of a combination product.
  • Works with the External and Internal Partners to ensure that effective and robust MDCP Quality Systems and Quality management are in place.
  • Provides guidance in the preparation of metrics, procedures and guidelines.
  • Provides proactive support in training and coaching to initiate quality improvements within Development, Operations and Quality.
  • Audits and approves Design Control and Device Risk Management GMP documentation for applicable regulatory filings, clinical supply, development and design transfer qualification.  Ensure compliance with regulatory and Merck requirements.  Evaluate deficiencies and assess impact on compliance status. 
  • Contributes to developing/revising policy and procedures for MDCP Quality and /or supported areas.
  • Supports preparations for regulatory agency inspections with focus on relevant MDCP regulations and Quality system requirements.

            - Remains informed of current GMP requirements and industry trends as described in worldwide regulations and industry standards. 

            - Maintains an expert level of knowledge related to a specialized area of expertise.


Education Minimum Requirement:

  • B.S. degree in an appropriate Science or Engineering discipline. 
  • Minimum of ten (10) years’ experience or a Ph.D. in Engineering or Science with five (5) years’ experience. 

Required Experience and Skills:

  • Expert knowledge of ISO 14971:2012. 
  • Led development and maintenance of Device Risk Management files. 
  • Extensive knowledge of medical device regulations (21CFR820)
  • Demonstrated ability to work effectively in teams. 
  • Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others. 
  • Ability to work in a high matrix organization. 
  • Effective written and oral communicator. 
  • Able to speak up and contribute in a team forum. 
  • Able to apply prior experiences and learning in new settings, even if these are unfamiliar.

Preferred Experience and Skills:

  • Knowledge of current GMPs for combination products. 
  • Quality Assurance and Regulatory Compliance experience is a plus.  


Our employees are the key to our company’s success.  We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.  Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.  If you need an accommodation for the application process please email us at
Search Firm Representatives Please Read Carefully: 
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
For more information about personal rights under Equal Employment Opportunity, visit:


Job Clinical, Non Clinical Quality Assurance

Primary Location NA-US-NJ-Whitehouse Station West

Other Locations NA-US-PA-Upper Gwynedd, NA-US-PA-West Point, NA-US-New Jersey

Employee Status Regular

Number Of Openings 2

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