Senior Quality Engineer
Genesis Innovation Group
full-time
Posted on:
Location Type: Remote
Location: Missouri • United States
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Job Level
About the role
- 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
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality control processesquality assurance policiesrisk managementdata analysisgap analysisGeometric Dimensioning and Tolerancingcomplaint handlingCAPA handlingdesign controlsquality control systems
Soft Skills
attention to detailproblem-solvingcommunicationteamworktraininganalysiscritiqueinterpersonal skillsorganizational skillsleadership
Certifications
Bachelor of Science in Engineeringrelated degree