Not specified (assumed to be hybrid based on industry norms).
Bachelor's degree in engineering
7+ years progressive engineering experience
Fda regulations and qms knowledge
The Integer Group is seeking a Senior Quality Engineer to ensure the quality and compliance of medical device manufacturing processes. The ideal candidate will have extensive engineering experience, a strong problem-solving foundation, and the ability to lead continuous improvement initiatives while adhering to regulatory standards
Job Summary
This role involves applying intensive engineering knowledge to ensure product quality and meet customer expectations in the medical device and battery manufacturing sectors.
The successful candidate will lead continuous improvement projects, manage non-conforming material processes, and support regulatory inspections and audits.
Candidates are expected to demonstrate strong problem-solving skills using statistical methods like Cpk and DOE while adhering to strict safety and quality values.
Matching Summary
Match Score: 85
The Integer Group is seeking a Senior Quality Engineer to ensure the quality and compliance of medical device manufacturing processes. The ideal candidate will have extensive engineering experience, a strong problem-solving foundation, and the ability to lead continuous improvement initiatives while adhering to regulatory standards.
Skills & Requirements
Must-have
Bachelor's degree in engineering
7+ years progressive engineering experience
FDA regulations and QMS knowledge
Statistical quality control (Cpk, DOE)
CAPA and complaint investigation leadership
Nice-to-have
Master's degree in engineering field
Six Sigma Black Belt certification
ISO and international regulatory awareness
Mentoring and supervising engineering teams
5 Sigma journey participation
Key Requirements
Minimum Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
Knowledge of FDA regulations and Quality Management Systems
Six Sigma Green Belt minimum (Black Belt preferred)