Associate Director Medical Devices Combination Product CAPA, Quality System Improvement Program

  • Company: Merck
  • Location: New Jersey, United States
  • Posted: November 10, 2016
  • Reference ID: QUA005234
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 Executive Director Medical Device and Combination Product Quality (MDCPQ), responsible for independent support of complianct 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 with a focus on Device CAPA. In addition, the Medical Device Combination Product (MDCP) Quality Associate Director is responsible for planning and program execution relating to Medical Device Combination Product projects.

Primary Responsibilities include:
  • Supports maintenance, knowledge transfer, and as needed development of Merck's Device specific Quality Management System.
  • Participates on Merck teams supporting (MDCP) Current Good Manufacturing Practice (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., M.S., and/or Ph.D. degree in an appropriate Science or Engineering discipline. Minimum of ten (10) years' experience with BS/MS or three (3) years' experience with Ph.D. in pharmaceutical / engineering/ academia with medical devices.
Required Experience and Skills:
  • Expert knowledge of medical device regulations and compliance in a specialized area with experience in their application, including current GMPs for combination products.
  • 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.
  • Effective written and oral communicator.
  • Able to speak up and contribute in a team forum.
  • Able to apply prior experiences and learnings in new settings, even if these are unfamiliar.
Preferred Experience and Skills:
  • Working knowledge of technical aspects of device development and commercialization.
  • Development, product approval, and/or inspection experience with the medical device constituent of a combination product is an asset.
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
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Visa sponsorship is not available for this position.

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