Associate Director, Device Quality
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck inthe United States and Canada, is a global health care leader with a diversifiedportfolio of prescription medicines, vaccines and animal health products. The differencebetween potential and achievement lies in the spark that fuels innovation andinventiveness; this is the space where Merck has codified its legacy forover a century. Merck’s success is backed by ethical integrity, forwardmomentum, and an inspiring mission to achieve new milestones in globalhealthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energeticindividuals who are committed to being the most trusted supplier ofpharmaceuticals and health products worldwide. Our facilities, along with ourexternal contractors, suppliers, and partners, comprise an interdependentglobal manufacturing network that’s committed to delivering a compliant,reliable supply to customers and patients on time, every time, across theglobe.
Position reports to the Director Medical Device and CombinationProduct Quality (MDCPQ), responsible for independent compliance support ofMedical Devices including the device constituent part of Combination Products.This position will interact with cross functional teams working with all levelsof employees. Activities will include developing, documenting, and maintenanceof technical business solutions or audits of data, policies, procedures, andsystems to ensure compliance with Medical Device (21CFR 820s) and CombinationProduct current Good Manufacturing ruling (21CFR part 4), Device RiskManagement (ISO 14971) and other worldwide regulations and Merckrequirements.
The primary purpose of this position is to provide Device QA support andleadership to ensure sustaining/remediation activities and successful qualityoversight of prospective combination products. This individual will be expectedto apply his/her knowledge of product development, design control principles,risk management and quality engineering techniques to positively influencecommercial and new product launches to ensure they are developed andmanufactured in accordance with regulatory, company, and customer requirements.Will review and evaluate scientific and technical data as it pertains toproduct and product testing and lead teams to identify and solve complexproduct problems.
- Actively represent Device DesignQuality function on commercial and product/core development teams supportingquality issues related to medical devices or the device constituent of acombination product.
- Review and approve Design Control andDevice Risk Management documentation for regulatory filings, clinical supply,development and design transfer qualification. Evaluate deficiencies and assessimpact on compliance status.
- Contribute to developing/revisingpolicy and procedures for MDCP Quality and/or supported areas.
- Remain informed of industry trends asdescribed in worldwide regulations and industry standards.
- Provide guidance to MMD and MRL devicefunctions and other personnel to ensure end-to-end Quality by Design, SixSigma, Reliability, and Design Control principles are implementedeffectively.
- Participate in design reviews, CAPAreviews, and ad-hoc technical reviews of combination products.
- Be a hands on participant in all stagesof combo product development including but not limited to oversight ofpurchasing controls and supplier quality.
- Work with external partners to developproducts.
- Author retrospective design control documentationthat encompasses the life-cycle and risk-based approach of development andsustaining activities.
- Review and approveverification/validation test protocols and reports to ensure that the testingis sufficient to meet regulatory requirements and quality objectives.
- Provide input to design andmanufacturing documentation including material specifications, drawings,inspection procedures, and manufacturing procedures, to ensure that theresulting products can be adequately manufactured and tested.
- Facilitate translation of vaguecustomer needs into critical to quality and design input/output requirements,including but not limited to chemical, physical, or performancespecifications.
- A Bachelor’s degree in (Science orEngineering or associated fields) with a minimum of 10 years related experienceOR a Master’s degree (Science or Engineering or associated fields) and 7 yearsrelated experience OR a Ph.D. (Science or Engineering or associated fields) and5 years of related experience. Advanced degrees may be used reduce requiredexperience.
Required Experience and Skills:
- Extensive knowledge/experience withquality tools
- Design Controls / CAPA / PurchasingControls asit related to 21CFR820
- Risk analysis (ISO 14971)
- Medical Device & CombinationProduct regulations (ISO 13485/11608, IEC 62304, 21CRF part 820, 210/211 and 4).
- Must be able to work independentlywithin a cross functional framework and will involve detailed technical writingand review. A high degree of creative thinking, resourcefulness, and networkingwill be required to coordinate projects or solve problems.
- Effective communication skills andworking knowledge of device development and commercialization, productapproval, and/or regulatory inspection experience with the medical deviceconstituent of a combination product.
- High proficiency with statistical tools(e.g., Minitab or Sigma XL) is required. Strong technical writing skills arerequired.
- Must be a technical expert, workindependently, and have excellent interpersonal relationship skills withflexibility to adapt to fast pace environment with changing priorities.
- Certified Lean Six Sigma Green Belt orBlack Belt and/or Certified Quality Engineer (CQE) strongly desired
- Strong understanding of GoodManufacturing Practices (GMP), Good Documentation Practices (QDP); and projectmanagement principles is desirable.
- Lean Six Sigma Principles and toolssuch as: DOEs, Root cause analysis and/or Problem solving methods are desired.
- Experiencein the use of root cause analysis and applied statistical techniques.
Your role at Merck is integral to helping the world meet newbreakthroughs that affect generations to come, and we’re counting on yourskills and inventiveness to help make meaningful contributions to globalmedical advancement. At Merck, we’re inventing for life.
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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