Johnson & Johnson Careers
Staff Quality Engineer
Palm Beach Gardens, Florida
Requisition ID: 1317181228
DePuy Synthes, a member of the Johnson & Johnson Family of Companies, is currently recruiting a Staff Quality Engineer to join its team, located in Palm Beach Gardens, Florida.
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.
The Staff Quality Engineer has site-wide quality responsibility for all Validation for Process, Methods and Equipment. With this authority this position leads key validation projects, manages the of Validation project portfolio and sets the strategic direction for the Validation program for the site. This position is responsible to maintain validation processes in compliance with applicable regulations (QSR, ISO 13485, GHTF).
•Develop, implements and monitors the validation strategy for the site that are aligned with the business strategy.
•Review and approve IQ, OQ, PQ, TMV or Software Validation.
•Ensures the appropriate sampling plans are implemented in conjunctions with level of validation.
•Directing and overseeing validation activities
•Keeping up to date on industry standards and regulations
•Conduct benchmarking with external companies or internal sites to develop more effective methods for improving quality.
•Collaborates with others to identify required quality engineering skills and competencies to enable effective execution of the strategic vision.
•Provide input for business planning, project prioritization and resource requirements.
•Lead quality improvement teams and may supervise others.
•Act as a mentor to less experienced Quality Engineers to help develop QE capabilities within the QE organization.
•Review/analyze whether current product and processes are in compliance to standards such as the QSRs, ISO 13485, etc. C
•Champion compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
•Review effectiveness of preventive and corrective actions and review root cause investigations according to an established process.
•Supports the development of quality strategies related to the transfer of products, materials and components within J&J or externally.
•Supports new product introduction as part of design transfer.
•Partners with J&J Global Supply chain, finished goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
•Develop, interpret, implement and have ownership for standard and non-standard sampling plans.
•Develop and assess the effectiveness of measurement systems, destructive tests, and non-destructive tests for manufacturing processes.
•Document, justify, review or analyze whether a proposed change to a process will enhance the risk level in some way beyond capability of current controls or whether the change will result in potential non-compliance to a required standard.
•A minimum of a Bachelor’s Degree is required, preferably in Engineering or related technical field.
•A minimum of 6 years of related experience required.
•Experience working in FDA or European regulatory environment is required.
•This position will require relevant experience working in manufacturing/operations.
•In-depth knowledge of validation and product/process Risk Management is required.
•Experience and a proven track record of implementing appropriate risk mitigation is required.
•Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, and DOEs.
•Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
•The ability to perform "hands on" troubleshooting and problem solving is required.
•The ability to think on the feet and providing sound judgment is highly desired.
•Good technical understanding of manufacturing equipment and processes is required.
•Understanding of the NPI (New Product Introduction) process is preferred.
•A thorough understanding of GMP/ISO regulations and validation regulations is required.
•Strong mentoring, coaching and leadership skills are required.
•Advanced knowledge and proven leadership in the areas listed in the Duties and Responsibilities associated with the position.
•Demonstrated project management and project leadership abilities are required.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Florida-Palm Beach Gardens-
Depuy Orthopaedics. Inc. (6029)