Senior Quality Engineer II

Genesis Innovation Group•Grand Rapids, MI

10d

About The Position

We are looking to hire an experienced Senior Quality Engineer II. As the Senior Quality Engineer II, you will identify, analyze, critique, and correct quality control processes and documented procedures. In this role, you will also interact with a variety of suppliers and the Genesis family of companies to ensure consistency, accuracy, and the implementation of best practices. Genesis Innovation Group (GIG) is a unique Venture Capital and Business Development firm concentrated on medical devices. Our role as investors and industry partners is to focus on the creative power of entrepreneurs by leveraging our network, resources, and experience to ensure their success. Combined, we have more than a century of experience in the medical device space, and over two hundred patents and innovations to our names. In this role you will: 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 To keep up with our fast-paced, detail-driven business qualified candidates will have: 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 Why Join Genesis Innovation Group: If you are looking to further your career in a pioneering and evolving industry, consider joining our team of professionals. We value and appreciate our employees and will support you with great company culture and opportunities for professional growth. At Genesis Innovation Group, we provide competitive wages, a bonus program, benefits, and strong team collaboration. Apply today for immediate and confidential consideration to become our next Senior Quality Engineer II . To learn more about us, visit us online at www.genesisinnovationgroup.com.

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 with Design Controls and Risk Management required
Ability to work individually and on a team
Ability to solve quality issues with remote suppliers
High attention to detail

Nice To Haves

Experience in the medical device industry preferred
Experience with complaint and CAPA handling a plus
Geometric Dimensioning and Tolerancing experience a plus

Responsibilities

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