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 helping-hand 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 Quality Analyst is responsible for performing the day-to-day activities of maintaining the quality system and ensuring Tekna is functioning in compliance with the system.

What you'll get to do

• Device History Record (DHR) Lot Signoff: Ensuring device history record is complete and acceptable for finished products
• Document Control, Quality System Maintenance & Training: maintain updates, ensures documents and records are current and accessible. Ensures training is current for released procedures.
• Confirming Calibration of inspection and production equipment is completed as appropriate to provide accurate results
• Incoming inspection backup when needed
• Production testing and defect monitoring
• Internal Auditing
• Assist as necessary with the investigation, actions, and documentation of complaints, nonconformities, corrective actions, and returns
• Assist with external and supplier audits as needed

What you bring to the team

At least 1-3 years of experience in a quality analyst or technician role, skilled in working within a quality management systems and experience with internal audits.

• Error checking documentation and records to ensure they are complete and accurate and meet ISO standards
• Verifying Lot Signoff device history files are defined
• Clear communication skills, both written and verbal
• Ability to prioritize tasks based on customer expectations and impact to Tekna
• Self-starter with an analytical mindset
• Commitment to finding objective solutions through data and process improvement
• Proficiency with software programs, including Excel, Word, Outlook, and Adobe Acrobat

We want to work with people that reflect the communities in which we operate

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 accommodations.ta@ReBuildmanufacturing.com or you may call us at 617.909.6275.