Quality Engineer Iii

Integer

Not specified (assumed onsite or hybrid based on industry norms).
Fda quality system regulations compliance
Iso 13485 standards knowledge
Spc fmea doe process validation
Integer is seeking a Quality Engineer III who will ensure compliance with quality management systems and support product development in the medical device manufacturing sector. The role emphasizes strong communication, technical knowledge, and a commitment to safety and continuous improvement

Job Summary

  • The role requires maintaining company compliance with FDA Quality System Regulations and ISO 13485 standards while actively participating in internal audits.
  • Candidates will lead the implementation of continuous improvement projects and act as a subject matter expert for SPC, FMEA, and process validation.
  • The position involves providing direction to Product Development teams to successfully launch new products into active production in a timely and cost-effective manner.

Matching Summary

Match Score: 75

Integer is seeking a Quality Engineer III who will ensure compliance with quality management systems and support product development in the medical device manufacturing sector. The role emphasizes strong communication, technical knowledge, and a commitment to safety and continuous improvement.

Skills & Requirements

Must-have

  • FDA Quality System Regulations compliance
  • ISO 13485 standards knowledge
  • SPC FMEA DOE process validation
  • Bachelor's degree in engineering
  • 3 years manufacturing experience

Nice-to-have

  • Excellent verbal and written communication
  • Strong statistical analysis skills
  • ERP system familiarity
  • Geometric tolerance expertise
  • Continuous improvement project leadership

Key Requirements

  • Bachelor's degree in engineering or equivalent
  • Minimum 3 years working experience in manufacturing environment
  • Experience preferably in medical devices

Work Rights

Not specified

Tailored Resume

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