Senior Quality Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

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At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are personal. Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at MedTech

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be required regulatory approvals and other customary conditions and approvals.

Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

An internal pre-identified candidate for consideration has been identified. However all applications will be considered.

We are searching for the best talent for a Senior Quality Engineer located in Raynham MA.

The candidate will provide overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products. Conducts audits to good manufacturing practices international organization for standardization and any other applicable standards.

Duties and Responsibilities:

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 and quality compliance with the right skill sets for new product introductions and product life cycle management.
• Formulates and executes quality improvements.

Compliance/Regulatory

• 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 new product introduction as part of design transfer.
• Supports activities related to the 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.
• Represents as an Subject Matter Expert (SME)

Product/Process Qualification

• Support or leads in developing validation strategies.
• Approves IQ OQ PQ TMV or Software Validation.

Production/Process Controls including Control Plans

• Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.

• 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.

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.

Strategic

• Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.

Qualifications / Requirements:

• University/bachelors degree or Equivalent
• 4 to 6 years of relevant work experience and in the medical device environment is required.
• NR CAPA and audit experience is required.
• Strong trending and data analysis skills is required.
• Troubleshooting expertise is required.
• Process excellence/Six Sigma certification or equivalent is preferred.
• Analyze/review effectiveness of preventive and corrective actions. Review RCA investigations according to an established process.

Additional Information:

• The anticipated base pay range for this position is 77000 to 124200.
• The Company maintains highly competitive performance-based compensation programs. Under current guidelines this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis.
• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance.
• Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Companys long-term incentive program.
• Employees are eligible for the following time off benefits:
  • Vacation 120 hours per calendar year
  • Sick time - 40 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
  • Condolence Leave 30 days for an immediate family member: 5 days for an extended family member
  • Caregiver Leave 10 days
  • Volunteer Leave 4 days
  • Military Spouse Time-Off 80 hours
• Additional information can be found through the link below. job posting is anticipated to close on November 15 2025. The Company may however extend this time-period in which case the posting will remain available on to accept additional applications.

  Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

  Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please contact us via or contact AskGS to be directed to your accommodation resource.

  #LI-Onsite

  Required Skills:

  Preferred Skills:

  The anticipated base pay range for this position is :

  77000 to 124200

  Additional Description for Pay Transparency:

  The Company maintains highly competitive performance-based compensation programs. Under current guidelines this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance. Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys long-term incentive program. Employees are eligible for the following time off benefits: Vacation 120 hours per calendar year Sick time - 40 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 Condolence Leave 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave 10 days Volunteer Leave 4 days Military Spouse Time-Off 80 hours Additional information can be found through the link below. Experience:

  Senior IC