Senior Quality Engineer

Job Description

W2 only, no C2C or 3rd parties please

Candidates should have at least 4 (preferably 6+ years) of new product development experience with strong knowledge of product risk management (Hazard Analysis, DFMEA, UFMEA) and design verification testing (authorship and execution of product testing) . Candidates should also have experience with change control, CAPA, and ISO 13485 direct med device experience required ). There will likely be a strong preference for candidates with an understanding of software and hardware interface

Sr Quality Engineer (12 month contract / / Lafayette, CO) :

Top 3 Skills :

• Risk Management (Hazard Analysis, DFMEA, UFMEA)
• Design Verification Authoring and Execution
• NPD QE skillset (Change Control, CAPA, ISO 13485 understanding)

Education Required : Bachelors of Engineering

Years' Experience Required : 4+ years of product development and verification testing experience

Description :

The Senior Quality Engineer position supports new product development for Surgical Instruments . In this role, the Senior Quality Engineer works as part of the quality team supporting the cross-functional core team . knowledge includes mechanical and electromechanical design, design verification, design validation, process validation, risk management, and complaint analysis . As a member of the Quality Team, you will provide guidance and implement strategies that drive product quality and continuous improvement

Duties :

mechanical / electromechanical

project documentation , participating in product risk assessments , and working with Product Development to develop verification and validation testing requirements

Embedded Responsibilities :

Required Experience :

design / manufacturing

process knowledge (designing, troubleshooting, improving, qualifying designs for sustainable manufacturing of medical devices)

Management / Coordination

skills)

Experience :

engineering / Quality

experience

development / manufacturing

in compliance with Quality System Regulations, ISO 13485, ISO 14971, ISO 60601

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