Role Description 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 - 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. 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 in Science or Engineering or associated fields and 5 years related experience OR a Ph.D. in Science or Engineering or associated fields and 3 years of related experience. - 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. Requirements - US based – NJ/PA or other US location. - Travel – Yes, <10% of the time. Benefits - Comprehensive package of benefits including 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.