DePuy Synthes Companies of Johnson & Johnson is seeking a Quality Engineer II, located in Monument, CO.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
Provides overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products. Conducts audits to good manufacturing practices, international organization for standardization and any other applicable standards. Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes. Utilizes multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO). Addresses and corrects product and process complaints. Reports on contract manufacturer performance metrics and ensures management reviews. Oversees audits of all quality system categories to assess compliance to process excellence standards. Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management which outline. Handles complex technical issues for manufacturing processes that are to be transferred to satellite facilities.
Note: Shift will be determined as business need requires. Qualifications
Experience Level: 4-6 Years Work Experience
Education: A minimum of a Bachelor's degree is required preferably in engineering, technical, or life science.
• A minimum of 4 years of experience in a GMP and/or ISO regulated industry
• Experience in the Medical Device/ Pharmaceutical industry
• Knowledge with FDA CFR Part 820 and ISO 13485
• Auditing background
• Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and effects analyses
• Specification drawing literacy including GD&T is preferred
• Strong in root cause analysis skills
• Experience and/or knowledge with machining manufacturing processes
• Six Sigma, Lean, or ASQ Certification
This position is located in Monument, CO and will require up to 20% travel.
Depuy Orthopaedics. Inc. (6029)Job Function