Senior Quality Engineer

Job not on LinkedIn

🕒 January 22

🚗 Michigan – Remote

🚗 Michigan – Remote

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Genesis Innovation Group

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Genesis Innovation Group is a U. S. -based medical device development firm that partners with inventors and entrepreneurs to take medical technologies from ideation through engineering, regulatory clearance, manufacturing, and commercialization. The company provides end-to-end services including prototype development, additive and precision manufacturing, ISO 13485 and 510(k)/PMA regulatory support, clinical and market strategy, funding and business planning, and distribution and training for clinicians. With experienced multidisciplinary teams and industry relationships, Genesis guides clients through complex technical, quality, and commercial pathways to bring devices to market.

📋 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

🎯 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