Bachelor's degree in engineering or technical field
Knowledge of fda regulations and iso standards
**
Integer is seeking a Principal Quality Engineer to provide strategic quality guidance in manufacturing and regulatory compliance for medical technologies. The ideal candidate will have over 10 years of experience in engineering roles, with a strong focus on quality management systems and regulatory standards.
**
Job Summary
The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals while applying intensive knowledge of engineering principles.
You will lead regulatory and agency inspections, audits, and investigations regarding the control and assessment of product design and manufacturing quality.
As a subject matter expert, you are expected to solve unique and complex problems with a broad impact on the business while mentoring up to five direct reports.
Matching Summary
Match Score: 75
**
Integer is seeking a Principal Quality Engineer to provide strategic quality guidance in manufacturing and regulatory compliance for medical technologies. The ideal candidate will have over 10 years of experience in engineering roles, with a strong focus on quality management systems and regulatory standards.
**
Skills & Requirements
Must-have
10+ years progressive engineering experience
Bachelor's degree in engineering or technical field
Knowledge of FDA regulations and ISO standards
Leadership of regulatory inspections and audits
Expertise in CAPA and root cause analysis
Experience with QMS and Device History Records
Nice-to-have
Master's degree or Doctorate preferred
Experience with global customer base interaction
Ability to mentor and supervise engineering teams
Strong written and oral communication skills
Positive can-do attitude in high-energy environment
Key Requirements
10+ years of progressive engineering experience
Bachelor's degree in engineering or related technical field
Master's degree or Doctorate (Preferred)
Knowledge of Domestic and International Regulations (ISO, QSR, UL, MDD)