$120,450 - $176,660; not specified; comprehensive ...
Iso 14971 risk management
Design verification and validation
Fda quality system regulations
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, cash-based incentive program, and comprehensive benefits.
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; Comprehensive benefits package
Skills & Requirements
Must-have
ISO 14971 Risk Management
Design Verification and Validation
FDA Quality System Regulations
ISO 13485
Medical Device Directive
Root Cause Analysis
Statistical Methods
Nice-to-have
Collaboration and negotiation skills
Team leadership and coaching
Cross-functional team guidance
Supplier risk management initiatives
Key Requirements
7-10 years of experience
Bachelor’s Degree in Engineering or related field
Master’s Degree preferred
Experience interpreting design schematics and drawings