Senior Quality Engineer Clean and Pack , Orthopedics

Johnson & Johnson Innovative Medicine•Raynham, MA

4d•$79,000 - $127,650

About The Position

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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. Johnson & Johnson is recruiting for a Senior Quality Engineer Clean and Pack 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

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

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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits