- Support the Project Manager in the creation of a Design History File and ensure conformance/compliance.
- Initiate and maintain project plans that optimize product quality, project schedule, and project/product cost.
- Conduct necessary research.
- Establish product requirements.
- Support system design and development.
- Lead risk management.
- Support or lead regulatory analysis.
- Support the Production Engineer with 6M analysis as part of developing the production process.
- Support the Design Engineer and Production Engineer with Failure Mode and Effects Analysis (FMECA).
- Review design for basic safety requirements ensuring compliance to applicable safety standards.
- Conduct Design for Manufacturing Analysis.
- Support the release of engineering specifications.
- Support the Production Engineer in completing Process Flow and Layout Diagrams and Process V&V Decision Matrix
- Design and develop verification processes/procedures for incoming, in process, and final inspection in support of the established production processes.
- Bachelor of science degree in engineering preferred
- 1 to 3 years' experience as a Senior AQE and/or 10 or more years' experience in new product development preferred
- Proficiency in statistical analysis and control preferred
- Read blueprints
- Computer literacy
- Problem solving skills
- Communication skills
- Organizational skills
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Lead Advanced Quality Engineer - Kalamazoo, United States - Re:Build Manufacturing
Description
About Re:Build Manufacturing and Re:Build Tekna:Tekna was founded in 1988 in the heart of Southwest Michigan where creative vision and hard work laid the foundation for a business that continues to grow in a rapidly evolving industry. The rigor and attention to detail that comes with designing for the medical industry has awarded us success in supporting both major companies and start-ups from early stage development to commercialization. The same principles apply as we've expanded to serve customers in a wide variety of other industries including consumer and industrial goods, electronics, and appliances. Tekna's project portfolio is incredibly diverse covering medical, life science, consumer and industrial product categories. Tekna is largely client focused offering design consulting, contract manufacturing and original equipment manufacturing services. Tekna's cross functional teams include Design Engineering, Industrial Design, CAD, Procurement, Production and Quality which offers a friendly and supportive team atmosphere.
Re:Build Manufacturing is a family of industrial businesses combining cutting-edge enabling technologies, operational superiority, and strategic M&A to build America's next-generation industrial company. Re:Build leverages deep expertise in operations management and technology to supercharge the performance of its subsidiaries by implementing core technologies across industrial platforms in diversified growth markets. Our goal is to help revitalize the U.S. manufacturing base over the coming decades, creating substantial opportunities for our employees and the communities where we operate.
If you like a fast-paced environment where individuals can stretch and be challenged with a diverse set of projects, we offer a great deal of variety and empower our staff to take on as much responsibility as they can handle, offering a helping hand and experienced-based coaching and the support of a highly competent team. Our goal is to enable our employees to achieve their fullest potential, and through our association with Re:Build, provide avenues for personal and professional growth.
Who we are looking for
The Lead Advanced Quality Engineer is responsible to execute tasks in support of New Product Development to ensure product safety, efficacy, reliability, and compliance to applicable regulatory requirements. You will support quality system improvement projects as a quality system improvement team member and delegate and supervise the work of other AQEs/QEs assigned to your NPD projects.
Your day-to-day activities will include:
Re:Build Manufacturing is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, marital status, parental status, cultural background, organizational level, work styles, tenure and life experiences. Or for any other reason.
Re:Build is committed to providing reasonable accommodations for qualified individuals with disabilities in our job application procedures. If you need assistance or an accommodation due to a disability, you may contact us at or you may call us at
