Senior Quality Engineer

Johnson & Johnson•Raynham, MA

2d•Onsite

About The Position

Johnson & Johnson is seeking a Senior Quality Engineer to join their team in Raynham, MA. The company is committed to healthcare innovation, developing smarter, less invasive, and more personalized treatments within MedTech. Johnson & Johnson fosters an inclusive work environment that respects diversity and individual merit. It is important to note that Johnson & Johnson plans to separate its Orthopaedics business to form a standalone company, DePuy Synthes, within 18 to 24 months. Should this position be accepted, it is anticipated that the employee would transition to DePuy Synthes, with employment governed by their processes, policies, and benefit plans.

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
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year