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Senior Quality Engineer

3 months ago

Raynham, United States Johnson & Johnson Full time
Description

Are you an experienced Quality Engineer looking for a new and exciting challenge? Look no further Johnson & Johnson is seeking a Senior Quality Engineer to join our exceptional team in Raynham, MA

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 .

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

At Johnson & Johnson, we pride ourselves on our world-class products and our commitment to making a difference in the lives of people around the globe. As a Senior Quality Engineer, you will play a vital role in ensuring the quality of our products, maintaining our reputation as a leader in the industry. This is a unique opportunity to be part of a company that is dedicated to delivering innovative and life-changing healthcare solutions.

Key Responsibilities:
  • 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.
  • Conducts investigation, bounding, records documentation, review and approval of non-conformances, CAPAs and customer complaints. Raises quality issues as appropriate.
  • Accountability for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
  • Analyzes/reviews 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 Subject Matter Expert (SME).
  • Supports 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.
  • Collects data and executes/conducts various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
  • Documents, justifies, reviews or analyzes 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.

Qualifications

Education:
  • A Bachelor's degree or equivalent in Engineering or related scientific field is required.

Experience and Skills:

Required:
  • A minimum of four (4) years of relevant, professional work experience in the Medical Devices industry.
  • Strong knowledge of quality management systems and regulatory requirements (e.g., ISO 13485, FDA QSR).
  • Exceptional problem-solving and analytical skills, with the ability to identify root causes and implement effective solutions.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
  • Experience with CAPAs non-conformances, audits, and process validation.
  • Strong trending and data analysis skills.
  • Troubleshooting expertise.
  • 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.

Preferred:
  • Process Excellence / Six Sigma Certification or equivalent preferred.

Other:
  • This position will be located in Raynham, MA and may require up to 10% domestic or 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 .