Associate Director, Quality Assurance, Medical Device/Combination Product job in Wilson
|Employer:|| Merck & Co.|
|State:||North Carolina (NC)|
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.
This position will be a high level, individual contributor role on the Medical Device and Combination Product Quality team.
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.
Primary responsibilities include:
• 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.
• Participate 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.
Education Minimum Requirement:
• A Bachelor's degree in (Science or Engineering or associated fields) with a minimum of 7 years related experience OR
• A Master's degree (Science or Engineering or associated fields) and 5 years related experience OR
• A Ph.D. (Science or Engineering or associated fields) and 3 years of related experience.
Required Experience and Skills:
•Led and managed development of DHF (design history file) deliverables for medical devices.
•Extensive knowledge of applicable medical device regulations (21CFR820, MDD, ISO 13485).
•Experience with Design Controls / CAPA / Purchasing Controls as it related to 21CFR820.
•Risk Management experience (ISO 14971:2012).
•Effective communication skills and working knowledge of device development and commercialization, product approval, and/or regulatory inspection experience medical devices.
Preferred Experience and Skills:
•Remediation experience is desired.
•Knowledge of current GMPs for combination products.
•Regulatory Affairs experience is desired.
•Certified Lean Six Sigma Green Belt or Black Belt or ASQ (American Society for Quality) certifications are preferred.
•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 assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to email@example.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 GINA Supplement