Senior Quality Engineer – Orthopedics

Johnson & Johnson • Raynham, MA

19h • Onsite

About The Position

The Senior Quality Engineer provides overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products. This role also conducts audits to good manufacturing practices, international organization for standardization, and any other applicable standards. The position supports quality improvement initiatives, reviews and analyzes the effectiveness of various improvement tools and programs, and conducts benchmarking to develop more effective methods for improving quality. It also supports the development of quality engineering and compliance for new product introductions and product life cycle management, and champions compliance to applicable Global Regulations and standards. The role involves partnering 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. It supports new product introduction as part of design transfer and activities related to the Material Review Board. The Senior Quality Engineer conducts investigations, bounding, documentation, review, and approval of non-conformances, CAPAs, and customer complaints, and escalates quality issues as appropriate. Accountability and ownership for material identification, material segregation, and classification of defect types are key responsibilities. The role involves analyzing and reviewing the effectiveness of preventive and corrective actions, and reviewing root cause investigations. Accountability and ownership of Quality metrics, including maintenance and review of leading and lagging indicators of quality, are also part of the role. The Senior Quality Engineer represents as a Subject Matter Expert (SME) and supports or leads in developing validation strategies, approving IQ, OQ, PQ, TMV, or Software Validation. The role 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. Developing, interpreting, and implementing appropriate process monitoring and control methods consistent with the level of process/product risk, collecting data, and executing/conducting various analytical/statistical analysis and interpretation are also key functions. The role involves developing, interpreting, and implementing standard and non-standard sampling plans, assessing the effectiveness of measurement tools, destructive tests, non-destructive tests, and measurement system analysis. It also involves assessing and interpreting common versus special cause variation in manufacturing processing and determining the adequacy of current process limits. Documenting, justifying, reviewing, or analyzing whether a proposed change to a process will not enhance the risk level beyond the capability of current controls, or whether a change will result in potential non-compliance to a required standard, is also a responsibility. Assessing the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc., and ensuring effective quality strategies are created for the validation of test methods, process, and design are also key aspects of the role.

Requirements

• A minimum of a university/bachelor’s degree in Engineering or Equivalent is required.
• A minimum of 4 years of related work experience.
• Experience in Medical Device or regulated industry.
• NR, CAPA, Audit Experience.
• Strong Trending and data analysis skills.
• Troubleshooting expertise.

Nice To Haves

• Process Excellence / Six Sigma Certification or equivalent certification.
• Additive manufacturing experience

Responsibilities

• Provide overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products.
• Conduct audits to good manufacturing practices, international organization for standardization, and any other applicable standards.
• 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.
• Support the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
• Formulate and execute quality improvements.
• 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.
• 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.
• Partner 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.
• Support new product introduction as part of design transfer.
• Support activities related to the Material Review Board.
• Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints.
• Escalate 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.
• Represent as an Subject Matter Expert (SME).
• Support or lead in developing validation strategies.
• Approve IQ, OQ, PQ, TMV or Software Validation.
• Partner 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 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.
• Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
• 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.
• Ensure effective quality strategies are created for the validation of test methods, process and design.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees