Associate Director, Quality Assurance

Job Description Position Overview - Basic Functions & Responsibility Essential function(s) includes, but is not limited to: Reporting to the Senior Director of Device Quality and Regulatory (DQ&R), the Associate Director Quality Engineering & Quality Assurance is 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, reviewing and approving medical device/combination product documentation to support regulatory filings and 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 company requirements. This position provides Device quality engineering and quality assurance support and leadership to ensure successful quality oversight of prospective medical devices and medical device combination products. Primary Activities Primary activities include, but are not limited to: Actively represent DQ&R 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, design transfer qualification and post marketing surveillance. Evaluate deficiencies and assess impact on compliance status. Contribute to developing/revising policy and procedures for DQ&R Quality and/or supported areas. Remain informed of industry trends as described in worldwide regulations and industry standards. Provide guidance to our Manufacturing Division and our Research and Development Division device functions and other personnel to ensure end-to-end 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. 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 customer needs into critical to quality and design input/output requirements, including but not limited to chemical, physical, or performance specifications. Lead and manage development of Design and Development File deliverables for medical devices Skills 7 years of relevant work experience. Extensive knowledge of applicable medical device regulations (21CFR820, 21CFR Part 4, EU MDR, ISO 13485). Experience with Design Controls / CAPA / Purchasing Controls as it related to 21CFR820. Risk Management experience (ISO 14971/24971, ICH Q9). Effective communication skills and working knowledge of device development and commercialization, product approval, and/or regulatory inspection experience with medical devices. 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. Ability to work in a matrix organization and effective written and oral communicator. Preferred experience and skills: Remediation experience is desired. Knowledge of current GMPs for combination products. 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. Qualifications: 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 US based – NJ/PA or other US location Travel – Yes, Required Skills: Clinical Quality Assurance, Clinical Quality Assurance, Combination Products, Computer System Validation (CSV), Design Thinking, Detail-Oriented, External Partners, GMP Compliance, Good Clinical Practice (GCP), Good Manufacturing Practices (GMP), Interpersonal Relationships, Leading Project Teams, Lean Six Sigma (LSS), Manufacturing Audits, Manufacturing Compliance, Material Specifications, Medical Device Management, Medical Device Regulations, Medical Devices, Product Development, Project Management, Quality Assurance (QA), Quality Control Management, Quality Improvement Programs, Quality Standards {+ 2 more} US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. If you need an accommodation during the application or hiring process. We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts ( The primary location for this posting is: USA - New Jersey - Rahway Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is: $142,400.00 - $224,100.00 This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at . Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location. Additional location(s) Compensation Information: San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Remote Shift: 1st - Day Valid Driving License: No Hazardous Material(s): No #J-18808-Ljbffr Merck