$120,450 - $176,660; not specified; not specified ...
Iso 14971 risk management
Design controls and supplier controls
Design verification and validation
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; Not specified; Not specified
Skills & Requirements
Must-have
ISO 14971 Risk Management
Design controls and supplier controls
Design verification and validation
Process validation protocols
Root cause analyses investigations
FDA Quality System Regulations
ISO 13485 and Medical Device Directive
Nice-to-have
Collaboration, negotiation, and conflict resolution