Senior Quality Engineer (Design QA):
Merck USA

Merck USA
Whitehouse Station New Jersey
Requisition ID: QUA006220

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. 


The primary purpose of this position is to provide Device QA support and leadership to ensure sustaining/remediation activities and successful quality oversight of prospective combination products. This individual will be expected to apply his/her knowledge of product development, design control principles, and quality engineering techniques to positively influence commercial and new product launches to ensure they are developed and manufactured in accordance with regulatory, company, and customer requirements. Will review and evaluate scientific and technical data as it pertains to product and product testing and lead teams to identify and solve complex product problems.


Education MinimumRequirement:

  • A Bachelor’s degreein (Science or Engineering or associated fields) with a minimum of 7 yearsrelated experience OR a Master’s degree (Science or Engineering or associatedfields) and 5 years related experience OR a Ph.D. (Science or Engineering orassociated fields) and 3 years of related experience. Advanced degrees may beused reduce required experience.

Required Experienceand Skills:  


Knowledge/experience with qualitytools:

  • Design Controls /CAPA / Purchasing Controls
  • Risk analysis (ICH Q9and/or ISO 14971)
  • Medical Device &Combination Product regulations (ISO 13485/11608, IEC 62304, 21CRF part 820,210/211)
  • Have demonstratedability to work collaboratively in cross functional teams and networks; able tofoster cooperation in others.
  • Be an effectivecommunicator and working knowledge of device development and commercialization,product approval, and/or regulatory inspection experience with the medicaldevice constituent of a combination product.
  • High proficiency withMicrosoft Word, Microsoft Excel, Power Point and statistical tools (e.g.,Minitab or Sigma XL) is required. Strong technical writing skills are required.
  • Technical expertworking independently, and have excellent interpersonal relationship skillswith flexibility to adapt to fast pace environment with changing priorities

Preferred Experienceand Skills:

  • Experience in the useof root cause analysis and applied statistical techniques
  • Certified Lean SixSigma Green Belt or Black Belt and/or Certified Quality Engineer (CQE) orreliability engineer (CRE) are strongly desired.

Your role at Merck isintegral to helping the world meet new breakthroughs that affect generations tocome, and we’re counting on your skills and inventiveness to help makemeaningful contributions to global medical advancement. At Merck, we’reinventing for life. 


If you need anaccommodation for the application process please email us [email protected]


Search FirmRepresentatives Please Read Carefully: 

Merck & Co., Inc. isnot accepting unsolicited assistance from search firms for this employmentopportunity.  Please, no phone calls or emails.  All resumessubmitted by search firms to any employee at Merck via email, the Internet orin any form and/or method without a valid written search agreement in place forthis position will be deemed the sole property of Merck.  No fee will bepaid in the event the candidate is hired by Merck as a result of the referralor through other means.


Job: Quality Engineering
Other Locations:
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Basic Qualifications