Senior Quality EngineerLS Solutions • Lafayette, CO, US
Senior Quality Engineer
LS Solutions • Lafayette, CO, US
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job_description.job_card.job_descriptionActively participate in product development cycle by reviewing mechanical / electro-mechanical project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements. Assesses overall product risk by facilitating the development of risk management tools such as the risk management plan / report, hazard identification, risk analysis chart, complaint analysis, etc. Collect, analyze and interpret statistical data. Performs analyses and provide reports to management as required. Contributes to the successful completion of Design and Process Validation initiatives by planning / reviewing validation and qualification activities, as required. This may include oversight to System / Sub-system Requirements, Critical to Quality Matrix, Process Flows, Control Plans, Measurement Systems Analyses and Process Capability Analyses. Assisting with projects and assuring proper and consistent implementation of the quality engineering tools. Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives. MUST HAVE : MINIMUM REQUIREMENTS : EDUCATION REQUIRED : B.S. degree in Engineering, Math, Physical Science, or equivalent field with 5+ years of work experience in engineering or Quality Preferred : M.S. degree in Engineering, Math, Physical Science, or equivalent field with 4+ years of work experience in engineering or Quality YEARS OF EXPERIENCE : Nice to Have : 6+ years of experience in a regulated industry (2+ years of experience can be substituted for an Advanced degree in a related discipline) SPECIALIZED SKILLS OR EXPERIENCE : Fundamental understanding of electro-mechanical designs and manufacturing processes to support designing, troubleshooting, improving and qualifying the design to ensure the sustainable manufacturing of medical devices both internal and external. Experience in a regulated industry Experience with Minitab or similar statistical analysis tools Experience with Risk Management Tools Good interpersonal skills; Ability to work effectively in a team environment and build strong working relationships. Ability to work in a fast-paced environment; Ability to work well under pressure and maintain positive, enthusiastic attitude Strong attention to detail and accuracy. Ability to successfully balance and prioritize multiple ongoing projects / tasks (Project Management skills). High degree of initiative and self-motivation. Strong analytical skills and the ability to solve problems through analytical reasoning. ASQ Certified Quality Engineering (CQE) Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, 14971 and 60601 requirements Understanding of software and hardware interface. Mid-Senior level Contract Quality Assurance Industries Business Consulting and Services
Overview
Now Hiring! Validation, Automation Engineers, CSV Specialists, and Quality Engineers across the US for top pharmaceutical companies
Job Title : Sr Quality Engineer – Medical Device
Job Location : Lafayette, Colorado and North Haven, CT (Fully Onsite)
Type : W2 contract
Job Description -
Technical skills that are required for the role :
- Risk Management (Hazard Analysis, DFMEA, UFMEA)
- Design Verification Authoring and Execution
Education Required : Bachelors of Engineering, Years' Experience Required : 4
POSITION RESPONSIBILITIES MAY INCLUDE THE FOLLOWING AND OTHER DUTIES MAY BE ASSIGNED :
BASIC QUALIFICATIONS :
Nice to have :
Seniority level
Employment type
Job function
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