Senior Quality Engineer Clean And Pack , Orthopedics

Senior Quality Engineer Clean and Pack

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.

Johnson & Johnson is recruiting for a Senior Quality Engineer Clean and Pack to join our exceptional team in Raynham, MA. 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.

Key Responsibilities

• Champions compliance with applicable global regulations and standards, 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 or equivalent university degree in Engineering or related scientific field is required.

Experience and Skills: 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.

Preferred: Process Excellence / Six Sigma Certification or equivalent.

Other: This position may require up to 10% of domestic or international travel.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is: $79,000.00 - $127,650.00. Additional description for pay transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: 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 period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year