Not specified (suggested: hybrid, based on the nature of the role)
10+ years engineering experience
Fda regulations and qms knowledge
Process validation and capability studies
The Integer Group is seeking a Principal Quality Engineer to provide strategic quality guidance in the development and manufacturing of medical devices and specialized batteries. The ideal candidate should have over 10 years of relevant engineering experience, strong problem-solving skills, and a commitment to quality and compliance with regulatory standards
Job Summary
This role serves as a strategic authority providing quality guidance to support the company's goals in medical device and battery manufacturing.
The incumbent will lead regulatory inspections, manage non-conforming material processes, and ensure adherence to FDA regulations and Quality Management Systems.
As a subject matter expert, you are expected to mentor engineers, lead continuous improvement projects, and drive product transfers with a focus on innovation.
Matching Summary
Match Score: 85
The Integer Group is seeking a Principal Quality Engineer to provide strategic quality guidance in the development and manufacturing of medical devices and specialized batteries. The ideal candidate should have over 10 years of relevant engineering experience, strong problem-solving skills, and a commitment to quality and compliance with regulatory standards.
Skills & Requirements
Must-have
10+ years engineering experience
FDA regulations and QMS knowledge
Process validation and capability studies
Root cause analysis and CAPA management
Bill of Materials review expertise
Lead regulatory inspections and audits
Nice-to-have
Master's degree or Doctorate preferred
ISO and international standards awareness
Mentoring and supervising engineering teams
Continuous improvement culture adoption
Global customer interaction skills
Key Requirements
Bachelor's degree in engineering or related field
Minimum 10 years progressive engineering experience