Senior Quality EngineerZipRecruiter • Lafayette, LA, US
Senior Quality Engineer
ZipRecruiter • Lafayette, LA, US
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- serp_jobs.job_card.temporary
job_description.job_card.job_descriptionActively participate in product development cycle by reviewing 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 Organizational and communication skills (oral / written) ; able to work individually and in teams Problem solving and analysis skills B.S. in Engineering, Math, Physical Science, or equivalent with 5+ years of engineering or Quality experience Electro-mechanical 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 Initiative, self-motivation, strong analytical / problem-solving skills M.S. in Engineering, Math, Physical Science, or equivalent with 4+ years Bachelor's with 6+ years in a regulated industry ASQ Certified Quality Engineer (CQE) Knowledge of medical device Understanding of software and hardware interface
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
J-18808-Ljbffr
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Senior Quality Engineer • Lafayette, LA, US
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