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Senior Quality Engineer - 2406192153W

Description

Johnson & Johnson Depuy Synthes a member of the Johnson & Johnson Family of Companies is currently recruiting for a Senior Quality Engineer ! This position will be located in Raynham, MA.

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we in Johnson & Johnson are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

DePuy Synthes, Companies of Johnson & Johnson, is the largest, most comprehensive orthopedic and neurological business in the world, built upon the strong legacies of two phenomenal companies.

DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials.

Our broad array of inspired, innovative, and high-quality offerings helps advance the health and wellbeing of people around the world.

Position Summary:

Supporting on-site manufacturing of a wide array of orthopaedic products for the DePuy Synthes business. As a Senior Quality Engineer, you will play a critical role in ensuring flawless quality assurance and compliance with industry standards while driving quality and cost improvement initiatives and supporting strategic business projects.

Key Responsibilities:

• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.

• Review/analyze the effectiveness of 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 compliance for new product introductions and product life cycle management.

• Support or leads in developing validation strategies.

• Approves IQ, OQ, PQ, TMV or Software Validation.

• 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.

• 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.

• 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

• 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.

• 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 a Quality Subject Matter Expert (SME)

Qualifications

Education:

A minimum of a Bachelors or equivalent University degree is required, with a focus in Engineering or Supply Chain related field preferred.

Required:

• Minimum of 4 years of relevant, professional work experience.

• Experienced in a Medical Device and/or regulated manufacturing work environment.

• Process validation experience.

• Demonstrated track record in leadership of projects within a regulated environment.

• Strong interpersonal and communication skills & demonstrated ability to operate as part of a team.

• Track record of innovation and adaptability in project execution, with strong problem-solving skills.

• Proven competence to evaluate communicate and act upon significant risks, demonstrating leadership of the high standards of quality and compliance.

• Act with speed, flexibility, and accountability to achieve goals. Understands how own work impacts the enterprise and use understanding to make effective decisions and take actions and lead priorities effectively to deliver expected results.

Other:

• This position may require up to 10% domestic & international travel.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Primary Location NA-US-Massachusetts-Raynham

Organization Medical Device Business Services, Inc (6029)

Travel No

Job Function Quality Engineering

Req ID: 2406192153W