Staff Quality Engineer

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 https://www.jnj.com

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Raynham, Massachusetts, United States of America

Job Description:

Johnson & Johnson is currently seeking a Staff Quality Engineer to join our exceptional team in Raynham, MA.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re 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 https://www.jnj.com/medtech

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.

Are you an experienced Quality Engineer looking for a new and exciting challenge? Look no further and join our team!

Key Responsibilities:

• Champions compliance with 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 Bachelors 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 a