Johnson & Johnson Careers
Staff Quality Engineer, Base Business
Requisition ID: 5220180627
The Ethicon Surgical Care business a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Staff Quality Engineer located in Cornelia, GA.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
You, the Staff Quality Engineer devises or adapts new methods or procedures to control or coordinate all aspects of several projects simultaneously and in the solution of technical and related projects. The staff engineer is an emerging authority in a specific technical field, exercising considerable latitude in determining technical objectives of assignments. Work is generally expected to result in the development of new or refined methods to reduce risk, equipment, materials, processes, products and or technical methods.
You, will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. You, will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. Support processes in base business and supervise or lead technicians.
Responsible for CAPA Site Lead for Cornelia, Athens and Somerville Plant. Responsibilities include facilitating operations of the CAPA System. Ensures effective communication and training are deployed throughout the business. The CAPA site lead is responsible for leading site CAPA activities including: Administration of the CAPA systems, facilitation of the local data review board and management reviews, coordination and support of CAPA project teams, data trending and CAPA reporting and communication with management and team leaders. The CAPA Site Lead is an influential position within the Operations organization that employs effective communication, influencing, and interdependent partnering skills to drive results and ensure the viability of the CAPA processes.
ESSENTIAL FUNCTIONS/DUTIES, RESPONSIBILITIES, AND AUTHORITIES:
- Business Improvements
- 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 to develop more effective methods for improving quality.
- Supports the development of quality engineering, quality compliance, quality leadership talents 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 in compliance 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 periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.
- New Product/Process Introduction
- 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.
- Provides supervision, mentoring, coaching, performance review, developmental plans, and succession planning for others
- Product Quality, Control & Disposition and Performance Standards
- Lead and maintain Material Review Board.
- Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
- Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
- Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
- Product/Process Qualification
- Approve IQ, OQ, PQ, TMV or Software Validation
- Production/Process Controls including Control Plans
- 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.
- Conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan
- Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes
- Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
- 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 and day-to-day support.
- Develop, interpret and implement standard and non-standard sampling plans
- Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
- Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standard for manufacturing data.
- Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
- Risk Mitigation
- Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
- Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements
- Conduct strategic planning with site leaders and Product Engineering Team. Partnership with other functions to establish business priorities and resource allocation
- Ensures effective quality strategies are created for the validation of test methods, process and design.
- Bachelor’s degree is required, with a degree in Engineering, Science or related discipline preferred. Advanced degree is preferred
- This role requires (6-8) years of related experience.
- Minimum of 5 years’ experience in Operations, Engineering and/or Quality Assurance is required.
- Background in Medical Device Industry, preferred
- Experience leading CAPAs is an asset.
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc
- Knowledge of regulatory requirements (ISO, QSR, etc.), preferred
- Working knowledge and practical experience utilizing Design of Experiments is highly preferred.
- Experience with external auditing bodies, preferred
- An ASQ certification (CQE, CQM, CRE, CQSR or CQA) is an asset. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification with demonstrated problem-solving and statistics skills, is an asset.
- Demonstrated project management skills with strong results orientation, 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.
- Work Environment: Frequent travel, Flexible to work on different shifts.
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.
Ethicon Inc. (6045)