Associate Director, Device Quality Job

Employer
Merck
Location
Whitehouse Station, NJ, US
Posted
October 12 2017
Discipline
Other
Organization Type
Pharma
Requisition ID: QUA006212

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. 



 

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
requirements. 



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
product problems. 



 

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
    combination product. 
  • 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
    effectively. 
  • 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
    products.
  • Author retrospective design control documentation
    that encompasses the life-cycle and risk-based approach of development and
    sustaining activities. 
  • 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
    specifications. 



Qualifications

Education/Experience Minimum
Requirement:



  • 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
    experience.


Required Experience and Skills:



  • Extensive knowledge/experience with
    quality tools 
  • Design Controls / CAPA / Purchasing
    Controls as
    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
    required.
  • 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.
  • Experience
    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 staffingaadar@merck.com.



  

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:



 

            EEOC Poster

            EEOC GINA Supplement 



Job: Qual Assurance & Ops Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

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