Senior Quality Engineer

Johnson & Johnson Innovative Medicine • Raynham, MA

1d • $79,000 - $127,650 • Onsite

About The Position

At Johnson & Johnson, the Senior Quality Engineer will join an exceptional team in Raynham, MA. The company is planning to separate its Orthopaedics business to establish a standalone orthopaedics company, DePuy Synthes, within 18 to 24 months. Upon completion of this transaction, the successful candidate would become an employee of DePuy Synthes. This role is within MedTech, a segment focused on innovation at the intersection of biology and technology, developing the next generation of smarter, less invasive, more personalized treatments. The position is crucial for ensuring compliance with global regulations and standards, managing quality metrics, and supporting validation strategies within the manufacturing and supply chain processes.

Requirements

• A Bachelors or equivalent university degree in Engineering or related scientific field is required.
• A minimum of 2-4 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.

Nice To Haves

• Process Excellence / Six Sigma Certification or equivalent.

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.

Benefits

• Consolidated retirement plan (pension)
• Savings plan (401(k))
• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 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
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees