Job Function: Supply Chain Engineering
Job Sub Function: Quality Engineering
Job Category:Scientific/Technology
All Job Posting Locations:San Jose, California, United States of America
Job Description:About MedTechFueled 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.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:
- 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.
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.
#LI-Hybrid
Required Skills:Preferred Skills:Customer Centricity, Data Savvy, Document Management, Execution Focus, Good Automated Manufacturing Practice (GAMP), Issue Escalation, Lean Supply Chain Management, Process Control, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy
The anticipated base pay range for this position is :$75,000.00 - $120,750.00
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
The following link to general company benefits information MUST also be included in the posting: Please use the following language:
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
