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 . Preferred 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 :
Actively participate in product development cycle by reviewing mechanical / electromechanical project documentation , participating in product risk assessments , and working with Product Development to develop verification and validation testing requirements .Assess product risk by facilitating risk management tools such as the risk management plan / report, hazard identification, risk analysis chart, complaint analysis , etc.Collect, analyze, and interpret statistical data ; provide reports to management.Contribute to Design and Process Validation initiatives by planning / reviewing validation and qualification activities (System / Sub-system Requirements, Critical to Quality Matrix, Process Flows, Control Plans, Measurement Systems Analyses, Process Capability Analyses).Assure proper implementation of quality engineering tools .Provide solutions to a wide range of difficult challenges ; work independently to develop practicable solutions consistent with organizational objectives .Embedded Responsibilities :
Organizational and communication skills (oral / written) ; able to work individually and in teams .Problem solving and analysis skills .Required Experience :
B.S. in Engineering, Math, Physical Science, or equivalent with 5+ years of engineering or Quality experienceElectro-mechanical design / manufacturing process knowledge (designing, troubleshooting, improving, qualifying designs for sustainable manufacturing of medical devices)Experience with Minitab (or similar statistical tools)Experience with Risk Management ToolsStrong interpersonal skills ; effective in team environmentsFast-paced environment adaptability ; able to work under pressure with a positive attitudeStrong attention to detail and accuracy ; ability to balance / prioritize multiple projects (Project Management / Coordination skills)Initiative, self-motivation, strong analytical / problem-solving skillsPreferred Experience :
M.S. in Engineering, Math, Physical Science, or equivalent with 4+ years engineering / Quality experienceBachelor’s with 6+ years in a regulated industryASQ Certified Quality Engineer (CQE)Knowledge of medical device development / manufacturing in compliance with Quality System Regulations, ISO 13485, ISO 14971, ISO 60601Understanding of software and hardware interface