DePuy Synthes Companies of Johnson & Johnson is seeking a Senior Manager, Quality Engineering Operations, located in Palm Beach Gardens, NY.
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.
Ensure the appropriate Quality Operation Leadership is available at all times and skills and competencies are consistent with present and future needs, verifying that Quality Systems are in place to maintain the required compliance level across the manufacturing site, and driving Quality System efficient execution and reduce risk of non-conforming product Manages the day-to-day operations of the Quality Engineering and Quality Systems staff. Oversee the development and implementation of processes, procedures, audits and corrective actions. Ensures effective communication and training are deployed throughout the business.
POSITION DUTIES & RESPONSIBILITIES:
• Support the development of quality engineering, quality compliance, and quality leadership talents with the right skills sets for new product introductions, and product life cycle management.
• Utilize Quality Engineering tools and methods for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
• Ensure effective risk management to prevent unanticipated failure modes and improve capability of processes.
• Lead or 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.
• Conduct benchmarking with external companies or internal sites to develop more effective methods for improving quality.
• Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc..
• 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.
• Accountability and ownership for material identification, material segregation, and classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
• Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality.
• Approve IQ, OQ, PQ, TMV or Software Validation.
• Lead personnel and activities to establish and maintain quality systems for stock evaluation/ hold/ releases, field actions, customer complaints, and CAPAs. This includes trending, analysis and reporting of quality metrics.
• Provide a contact point for all Recalls/ Stock Evaluations/ Stock Holds for product monitoring appropriate and timely completion of investigation, analysis, bounding, corrective action and documentation.
• Own the site activities related to CAPA processes. Within CAPA, responsibilities will include the oversight of: owner assignments, root cause analysis, CAPA plan development, and verification of completion/ effectiveness while owning the overall timeliness of the site’s CAPA activities.
• Standardize and develop methods/techniques of analytical/statistical analysis and interpretation; these may include descriptive, graphical, gage R&R/measurement system, reliability, capability, control chart analysis, confidence intervals, hypothesis testing, analysis of variance, design of experiments, etc. This individual will
• Ensure active participation and support for all Health & Safety related activities. Also, ensure that all Health & Safety requirements are fulfilled in accordance with the responsibilities defined in the Company Safety Statement, as well as actively promote Health & Safety within the department and ensure Health & Safety is a goal for all direct reports.
• A minimum of a Bachelor Degree is required preferably in Engineering, Quality or a related technology field.
• A minimum of 5 + years Quality experience in a GMP and/or ISO regulated environment is required.
• A minimum of 4 years’ experience managing direct reports is required.
• Experience working in an FDA regulatory environment is required, European is a plus
• Experience working in manufacturing/operations is required.
• Product/process Risk Management experience is required.
• Advanced Technical Training and experience using Statistics, Lean and Six Sigma Methodologies is preferred, including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• 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.
• Technical understanding of manufacturing equipment and processes is preferred.
• Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
• This position will be based in Palm Beach Gardens, FLA and requires up to 10% travel.