.DePuy Synthes (a member of Johnson & Johnson Family of Companies), is currently seeking a Staff Quality Engineer to join our outstanding team located in Raynham, MA!
At Johnson & Johnson, we believe health is everything.Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.
Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.In this role you will provide overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products.
You will be responsible to conduct audits for good manufacturing practices, international organization for standardization and any other applicable standards.Key Responsibilities: Developing and approving validation strategies, including but not limited to IQ, OQ, PQ, TMV or Software Validation for product/process qualification.Partner with R&D and other multi-functional partners to ensure the accurate application of design controls, risk management and the investigation/correction of design failures/challenges of new product/process introduction.Champion compliance to applicable Global Regulations and standards (e.G., QSRs, ISO, EN and Medical Device Directive (MDD) requirements).Supporting internal and external audits.Collaborate with multi-disciplinary teams to define and implement project strategies and action plans in support of product/process transfer projects.Conduct investigation, bounding, documentation, review, and approval of non-conformances, CAPAs and customer complaints.Escalating quality issues as appropriate.Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality.Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management.Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.Qualifications Education: Bachelor's degree or University equivalent in Engineering, Computer Science or STEM (Science, Technology, Engineering, Math) related field is required.Experience and Skills:Required:A minimum of four (4) years of relevant Quality Engineering experience required, Medical Device, Pharmaceutical or other highly regulated industry preferred