Johnson & Johnson Careers
Quality Engineer - DePuy Synthes
Requisition ID: 1390180906
DePuy Synthes Companies of Johnson & Johnson is seeking a Quality Engineer - DePuy Synthes to join the team in West Chester, PA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will 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, we are creating one organization that will be agile and better equipped in 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 Quality Engineer - DePuy Synthes plans, conducts and directs engineering projects or studies including complete projects requiring knowledge of a specialized field.
In this role, you will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle.
You will also use Quality Engineering principles and analytical skills to improve and maintain products/processes that align with the overall Quality and Business vision. You will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes.
Responsibilities include but are not limited to:
- Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
- Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
- Review/analyze whether current product and processes (including actions or decisions conducted) are compliant to standards, such as the QSRs, ISO 13485, etc.
- Champions 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.
- Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints.
- Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
- Support, review and approval for process validations (IQ, OQ, PQ), TMV, equipment or software validations.
- 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.
- Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements.
- Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
- A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field is required.
- A minimum of 2 years of related experience is required.
- Relevant experience working in manufacturing/operations is required.
- Process Validation (IQ/OQ/PQ) expertise is required
- Good technical understanding of manufacturing equipment and processes is required.
- Experience working in both an FDA and European regulatory environment is preferred.
- A thorough understanding of GMP/ISO and validation regulations is helpful.
- In-depth knowledge of product/process Risk Management (FDA and ISO standards) and a consistent track record of implementing risk mitigation is preferred.
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies (including SPC, DOEs, Reliability, etc.) is helpful.
- Working knowledge of statistical software packages with the ability to preview, graph, analyze, and present data in a way that facilitates/drives decision-making is helpful.
- Project management and project leadership abilities is preferred.
- This position will be based in West Chester, PA and may require up to 5% travel.
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.
United States-Pennsylvania-West Chester
Depuy Orthopaedics. Inc. (6029)