J&J Family of Companies Senior Quality Engineer in Monument, Colorado
DePuy Synthes, companies of Johnson & Johnson, is recruiting for a Senior Quality Engineer, 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.
The Senior Quality Engineer is responsible for providing overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products.
Conduct audits to good manufacturing practices, international organization for standardization and any other applicable standards.
Provide complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes.
Utilize 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).
Address and correct product and process complaints. Reports on contract manufacturer performance metrics and ensures management reviews.
Oversee audits of all quality system categories to assess compliance to process excellence standards.
Ensure 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: Depending on business needs shift hours may fluctuate. Ability to have a flexible work schedule is required. (Primarily 1st shift hours however start/end time may be adjusted by a few hours)
A minimum of a Bachelor's degree is required preferably in engineering, technical, or life science.
A minimum of 4 years of experience in medical device, pharma or another highly regulated industry is required.
Knowledge with FDA CFR Part 820 and ISO 13485.
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.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Depuy Orthopaedics. Inc. (6029)