$120,450 - $176,660; not specified; not specified ...
Iso 13485
Fda quality system regulations
Iso 14971
The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures
Job Summary
The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures.
As a quality Core Team member, plays a key role on development project teams, performing quality/reliability engineering activities while providing guidance and expert advice.
Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success, including base salary, incentive program, comprehensive benefits, and 401(k) matching.
Matching Summary
The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures.
Salary
$120,450 - $176,660; Not specified; Not specified
Skills & Requirements
Must-have
ISO 13485
FDA Quality System Regulations
ISO 14971
Risk Management
Design Controls
Process Validation
Nice-to-have
Collaboration and negotiation skills
Coaching and team leadership
Lean Sigma tools proficiency
Medical device sterilization process knowledge
Key Requirements
Bachelor’s Degree in Engineering or related field
7-10 years of experience
Experience with FDA and European regulated medical devices