Quality Engineer Ii

Johnson & Johnson

Raynham, Massachusetts, United States of America
Base: $65,000.00 - $104,650.00; bonus/equity: elig...
Global regulations and standards compliance
Investigate non-conformances and capas
Material identification and segregation
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

Job Summary

  • 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.
  • 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.

Matching Summary

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.

Salary

Base: $65,000.00 - $104,650.00; Bonus/Equity: Eligible for long-term incentive program; Benefits: Vacation, Sick time, Holiday pay, Work/Personal/Family Time, Parental Leave, Bereavement Leave, Caregiver Leave, Volunteer Leave, Military Spouse Time-Off

Skills & Requirements

Must-have

  • Global Regulations and standards compliance
  • Investigate non-conformances and CAPAs
  • Material identification and segregation
  • Process validation strategy development
  • Data analysis and interpretation

Nice-to-have

  • Act with speed and accountability
  • Understand enterprise impact
  • Lead priorities effectively

Key Requirements

  • Bachelors or equivalent university degree in Engineering or related scientific field
  • 0-2 years of relevant professional work experience
  • Experience in the Medical Devices industry
  • Experience with CAPAs non-conformances, audits, and process validation

Work Rights

Not specified

Tailored Resume

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