Associate Director, Device Quality Job
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
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
Position reports to the Director Medical Device and Combination
Product Quality (MDCPQ), responsible for independent compliance support 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, policies, procedures, and
systems to ensure compliance with Medical Device (21CFR 820s) and Combination
Product current Good Manufacturing ruling (21CFR part 4), Device Risk
Management (ISO 14971) and other worldwide regulations and Merck
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,
risk management 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
This individual will:
- Actively represent Device Design
Quality function on commercial and product/core development teams supporting
quality issues related to medical devices or the device constituent of a
- Review and approve Design Control and
Device Risk Management documentation for regulatory filings, clinical supply,
development and design transfer qualification. Evaluate deficiencies and assess
impact on compliance status.
- Contribute to developing/revising
policy and procedures for MDCP Quality and/or supported areas.
- Remain informed of industry trends as
described in worldwide regulations and industry standards.
- Provide guidance to MMD and MRL device
functions and other personnel to ensure end-to-end Quality by Design, Six
Sigma, Reliability, and Design Control principles are implemented
- Participate in design reviews, CAPA
reviews, and ad-hoc technical reviews of combination products.
- Be a hands on participant in all stages
of combo product development including but not limited to oversight of
purchasing controls and supplier quality.
- Work with external partners to develop
- Author retrospective design control documentation
that encompasses the life-cycle and risk-based approach of development and
- Review and approve
verification/validation test protocols and reports to ensure that the testing
is sufficient to meet regulatory requirements and quality objectives.
- Provide input to design and
manufacturing documentation including material specifications, drawings,
inspection procedures, and manufacturing procedures, to ensure that the
resulting products can be adequately manufactured and tested.
- Facilitate translation of vague
customer needs into critical to quality and design input/output requirements,
including but not limited to chemical, physical, or performance
- A Bachelor’s degree in (Science or
Engineering or associated fields) with a minimum of 10 years related experience
OR a Master’s degree (Science or Engineering or associated fields) and 7 years
related experience OR a Ph.D. (Science or Engineering or associated fields) and
5 years of related experience. Advanced degrees may be used reduce required
Required Experience and Skills:
- Extensive knowledge/experience with
- Design Controls / CAPA / Purchasing
it related to 21CFR820
- Risk analysis (ISO 14971)
- Medical Device & Combination
Product regulations (ISO 13485/11608, IEC 62304, 21CRF part 820, 210/211 and 4).
- 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.
- Effective communication skills and
working knowledge of device development and commercialization, product
approval, and/or regulatory inspection experience with the medical device
constituent of a combination product.
- High proficiency with statistical tools
(e.g., Minitab or Sigma XL) is required. Strong technical writing skills are
- Must be a technical expert, work
independently, and have excellent interpersonal relationship skills with
flexibility to adapt to fast pace environment with changing priorities.
Preferred Experience and Skills:
- Certified Lean Six Sigma Green Belt or
Black Belt and/or Certified Quality Engineer (CQE) strongly desired
- Strong understanding of Good
Manufacturing Practices (GMP), Good Documentation Practices (QDP); and project
management principles is desirable.
- Lean Six Sigma Principles and tools
such as: DOEs, Root cause analysis and/or Problem solving methods are desired.
in the use of root cause analysis and applied statistical techniques.
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 an accommodation for the application process
please email us at email@example.com.
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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.
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Job: Qual Assurance & Ops Generic
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck