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Senior Quality Engineer

Senior Quality Engineer

Redbock - an NES Fircroft companyLafayette, CO, US
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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 experience
  • Electro-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 Tools
  • Strong interpersonal skills ; effective in team environments
  • Fast-paced environment adaptability ; able to work under pressure with a positive attitude
  • Strong attention to detail and accuracy ; ability to balance / prioritize multiple projects (Project Management / Coordination skills)
  • Initiative, self-motivation, strong analytical / problem-solving skills
  • Preferred Experience :

  • M.S. in Engineering, Math, Physical Science, or equivalent with 4+ years engineering / Quality experience
  • Bachelor's with 6+ years in a regulated industry
  • ASQ Certified Quality Engineer (CQE)
  • Knowledge of medical device development / manufacturing in compliance with Quality System Regulations, ISO 13485, ISO 14971, ISO 60601
  • Understanding of software and hardware interface
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    Senior Quality Engineer • Lafayette, CO, US

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