Operations Quality Engineer

Johnson & Johnson • San Jose, CA

1d • Hybrid

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.

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

An 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.

Requirements

• Bachelor’s 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.

Nice To Haves

• 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.

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.

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 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: Mid Level