Senior Quality Engineer – Orthopedics

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

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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About 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 are searching for the best talent for a Senior Quality Engineer to be located in Raynham MA.

The Senior Quality Engineer provide an overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products. Also conducts audits to good manufacturing practices international organization for standardization and any other applicable standards.

You will be responsible for:

• 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.

• 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.

• 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)

• Support or leads in developing validation strategies.

• Approves IQ OQ PQ TMV or Software Validation.

• 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.

• 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.

• Ensures effective quality strategies are created for the validation of test methods process and design.

Qualifications

Education:

• A minimum of a university/bachelors degree in Engineering or Equivalent is required.

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.

Preferred:

• Process Excellence / Six Sigma Certification or equivalent certification.

• Additive manufacturing experience

Other:

• This position may require up to 10% of domestic and/or international travel.

Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics 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.

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 external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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Senior IC