Johnson & Johnson Careers
Staff Quality Engineer
Requisition ID: 0184180820
DePuy Synthes Companies of Johnson & Johnson is seeking a Staff Quality Engineer located in Palm Beach Gardens, FL.
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.
You, the Staff Quality Engineer will utilize Quality Engineering tools and methods for the development, transfer, and maintenance of products/processes throughout the product life-cycle.
Responsibilities include but are not limited to:
- You will utilize Quality Engineering principles and problem-solving skills to develop and optimize products/processes that are aligned with the overall Quality and Business vision.
- Lead or support quality improvement initiatives such as process and product characterizations.
- Conduct benchmarking with external companies or internal sites to develop more effective methods for improving quality.
- Establish metrics that are leading and lagging indicators of quality and have accountability and ownership of quality metrics.
- 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.
- Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
- 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.
- Conducts stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan.
- Develop control plans and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
- Approve IQ, OQ, PQ, TMV or Software Validation.
- Collect data and execute statistical analyses as part of process improvements. 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.
- Have ownership and accountability of risk assessment process including conducting, documenting, reviewing or maintaining current risk and hazard analysis documentation such as Process FMEAs given product/process changes.
- Ensure effective risk management to prevent unanticipated failure modes and improve capability of processes.
- A minimum of a bachelor’s Degree is required, preferably in Engineering or related technical field.
- You must have a minimum of 6 years of related experience.
- Experience working in both an FDA and European regulatory environment is preferred.
- This position will require relevant experience working in manufacturing/operations. In-depth knowledge of product/process Risk Management (FDA and ISO standards) 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, DOEs, Reliability, etc.
- 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 and Process Validation expertise is preferred.
- A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
- 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.
United States-Florida-Palm Beach Gardens
Depuy Orthopaedics. Inc. (6029)