Genesis Innovation Group

In the medical device development world, there is no other company like Genesis.

Senior Quality Engineer

QA EngineerQA EngineerFull TimeRemoteTeam 11-50H1B No SponsorCompany SiteLinkedIn

Location

Michigan

Posted

54 days ago

Salary

Not specified

Bachelor Degree6 yrs expEnglish

Job Description

• Identify, analyze, critique, and correct quality control processes and documented procedures • Interact with a variety of suppliers and the Genesis family of companies to ensure consistency, accuracy, and the implementation of best practices • Formulate or help formulate quality assurance policies and procedures • Review and provide input to design plans, user requirements, design inputs, test procedures, risk management file, and design outputs to understand the scope, requirements, and function of the systems • Ensure that products meet the organizations and customers’ quality and product integrity requirements • Support the product development team by providing analysis and expertise throughout the inspection process • Identify root causes of problems in the production process; recommend and/or implements corrective measures • Analyze data to identify trends in product quality or defects with a goal of mitigating and preventing recurrence and future defects • Ensure manufacturing processes comply with federal, state, local, and industry standards and regulations • Perform risk analysis as part of the risk management team • Perform gap analyses on standards and regulations as new customers are brought onboard and as new or revised standards are released • Conduct training on quality assurance concepts and tools • Monitor, manage and handle complaints, feedback, and non-conforming products • Find, devise, handle, and enforce corrective and preventative actions • Communicate with engineering and productions within an organization and with customers and suppliers on quality-related issues • Work within the QMS team to ensure the overall quality of a manufactured product • Create, support, and oversee documentation • Develop quality control systems • Analyze quality assurance test results to ensure that the end product meets the exact needs of the user

Job Requirements

  • Bachelor of Science in Engineering or related degree required
  • Specific Medical quality design experience required
  • Minimum of 6 years of related experience in a regulated environment
  • Experience in the medical device industry preferred
  • Experience with Design Controls and Risk Management required
  • Experience with complaint and CAPA handling a plus
  • Geometric Dimensioning and Tolerancing experience a plus
  • Ability to work individually and on a team
  • Ability to solve quality issues with remote suppliers
  • High attention to detail

Benefits

  • Competitive wages
  • Bonus program
  • Benefits
  • Strong team collaboration

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