Medical device fda/european regulatory requirements
Iso 14971 risk management
Design controls and supplier controls
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. Performs quality/reliability engineering activities while providing guidance and expert advice to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled.
Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success.
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
Skills & Requirements
Must-have
Medical device FDA/European regulatory requirements
ISO 14971 Risk Management
Design controls and supplier controls
Design verification and validation protocols
Root cause analyses investigations
Nice-to-have
Customer success focus
Innovation and collaboration
Respectful interaction
Open and honest communication
Integrity in actions
Key Requirements
Bachelor’s Degree in Engineering or related field
7-10 years of experience
Practical knowledge of FDA Quality System Regulations, ISO 13485