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Senior Specialist - Quality Assurance, Medical Device and Combination Products (MDCP)

Requisition ID: QUA008830

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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century . Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.


  • Review reportable external customer complaints,upon intake, for appropriateness for health authority submission
  • Document review/approval in complaint database
  • Collaborate with the Site Complaint Investigating Unit and MDCP -Technical Operations (TO) to ensure the device and device components are adequately considered as part of the root cause analysis and to ensure the design of the device and device components are adequately considered when manufacturing or packaging root causes are not identified.
  • Collaborate with Site Complaint Investigating Unit and MDCP TO to ensure robust corrective and/or preventive actions are put in place to address external customer complaints
  • Review the Device Risk Management Files to ensure the customer complaint being investigated is appropriately represented
  • Collaborate with MDCP TO to update the Device Risk Management files, as needed.
  • Review and approve reportable external customer complaint investigation reports prior to their submission to health authority


Education Minimum Requirement:

  • Bachelor's degree in engineering.
Required Experience and Skills:
  • At least 5 years experience in Pharma or Medical Device companies
  • Working knowledge of applicable medical device regulations (21CFR820, EU MDR, ISO 13485:2016), Risk Management Experience (ISO 14971:2012).
  • Demonstrate the ability to work effectively in teams. Must be able to work independently within a cross functional framework and will involve detailed technical writing and review.
  • A high degree of creative thinking, resourcefulness, and networking will be required to coordinate projects or solve problems.
  • Must work independently and have excellent interpersonal relationship skills with flexibility to adapt to fast pace environment with changing priorities. Ability to work in a matrix organization and effective written and oral communicator.
Preferred Experience and Skills:
  • Experience in Complaint Handling investigation process
  • Understanding of Combination Product regulations (21 CFR Part 4 including Post Market Safety Reporting requirements.

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to

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:

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of it's manifestations.

Job: Qual Assurance & Ops Generic
Other Locations: Whitehouse Station, NJ, US; Rahway, NJ, US; Wilson, NC, US
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 2
Shift (if applicable): 1st
Hazardous Materials: Yes
Company Trade Name: Merck

Nearest Major Market: Philadelphia

Senior Specialist - Quality Assurance, Medical Device and Combination Products (MDCP)

West Point, NY
Full Time

Published on 06/26/2019