Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and leadership in the medical device and specialized battery manufacturing sectors. The role emphasizes innovation, collaboration, and adherence to quality management systems
Job Summary
This role provides strategic quality guidance to support Integer's goals as a subject matter expert in the medical device industry.
The incumbent will lead regulatory inspections, manage non-conforming materials, and ensure compliance with FDA regulations and Quality Management Systems.
Candidates must have 10+ years of progressive engineering experience and demonstrate the ability to work independently while collaborating with cross-functional teams.
Matching Summary
Match Score: 85
Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and leadership in the medical device and specialized battery manufacturing sectors. The role emphasizes innovation, collaboration, and adherence to quality management systems.
Skills & Requirements
Must-have
10+ years progressive engineering experience
Bachelor's degree in engineering field
FDA regulations and QMS knowledge
Lead regulatory inspections and audits
Manage non-conforming material processes
Develop test method validation protocols
Supervise engineering direct reports
Nice-to-have
Master's degree or Doctorate preferred
ISO and international standards awareness
Strong written and oral communication
Positive can-do attitude
Experience with global customer base
Mentoring and coaching capabilities
5 Sigma journey participation
Key Requirements
10+ years of engineering experience
Bachelor's degree in engineering
Knowledge of FDA and ISO regulations
Master's degree or Doctorate (preferred)
US citizenship not explicitly required but US applicants noted