Operations Quality Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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.

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About MedTech

Fueled by innovation at the intersection of biology and technology were 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 internal pre-identified candidate for consideration has been identified. However all applications will be considered.

We are searching for the best talent for Operations Quality Engineer.

Responsibilities:

• Lead conduct and complete investigation documentation and containment actions related to nonconformances.
• Manage tracking and reporting of site nonconformance metrics and raises quality issues as appropriate.
• Accountability for material identification material segregation classification of defect types including documentation and tracking of material disposition to support on a day-to-day basis in manufacturing.
• Support the equipment calibration program including verification that calibration activities are performed on time and documented in accordance with procedures.
• Review calibration records and support investigation of out-of-tolerance conditions.
• Support impact assessments related to calibration failures on product quality and released product.
• Support preventive maintenance (PM) activities by verifying execution documentation and alignment to defined schedules.
• Ensure calibration and PM records are available and audit-ready.
• Assist in root cause analysis and verification of corrective and preventive action effectiveness (CAPA) and customer complaints as vital.
• With guidance assist Supply Chain to ensure appropriate application of process validation process control and risk management and the investigation/correction of process failures when needed.
• With guidance 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.

Qualifications:

Required:

• Bachelors degree or equivalent experience in Engineering Science or a related technical field.
• Basic understanding of quality management systems and regulatory requirements (e.g. ISO 13485 FDA QSR).
• Experience with CAPAs non-conformances audits and process validation.
• Knowledge of basic statistical tools and quality improvement methodologies.
• Experience supporting equipment calibration preventive maintenance or metrology systems.
• Experience in Quality Engineering or Quality Assurance of a regulated medical devices or other regulated industries.
• Ability to work multi-functionally in a manufacturing environment.

Preferred:

• Exposure to validation calibration and/or preventive maintenance activities preferred.
• Strong trending and data analysis skills with problem-solving and ability to identify root causes and implement effective solutions.
• Excellent communication and social skills with the ability to collaborate effectively with multi-functional teams.

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 and 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 please email the Employee Health Support Center() or contact AskGS to be directed to your accommodation resource

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