Quality Assurance (QMS) Supervisor

Job description

**About Streck**: Streck is a Nebraska-based manufacturing company that makes a global impact by developing and distributing to labs worldwide. Our products provide confidence for accurate health care testing! Our passions and priorities are focused on taking care of our customers, employees, and giving back to our community. Streck has jobs for every stage of your career. If you are a dependable, hard-working, and team-oriented individual who values meaningful work, Streck is looking for you to join our community of passionate people on a mission! Are you a quality professional who thrives on turning regulatory complexity into clear, practical action? Streck is looking for a Quality Assurance Supervisor to lead and develop our team of QA Specialists, championing product quality and regulatory compliance across our organization. In this role, you'll provide day-to-day coaching and technical guidance to your team, partner closely with the Quality Assurance Manager on strategic initiatives, and play a key role in maintaining the systems that keep our products safe, compliant, and best-in-class. **What You'll Do** - Recruit, hire, and train QA department employees, partnering with the QA Manager and HR to support your team - Manage schedules, timecards, PTO, and overtime for your team - Provide supervisory leadership and guidance to Quality Assurance Specialists, ensuring compliance with the Quality System and applicable regulations - Conduct regular performance evaluations, using them as a tool to motivate and develop your team - Partner cross-functionally to resolve nonconformances, production issues, and process improvement opportunities - Analyze monthly QA data to identify trends and compile quarterly metrics - Develop and deliver ongoing training on the Quality System, including tools and resources for your team - Support review of Deviation and Nonconforming reports, helping identify root cause and prevention strategies - Assist with internal audits and CAPA follow-up in conjunction with the QA Coordinator - Evaluate training practices for new hires and transfers alongside Operations Supervisors - Provide QA final approval of document revisions within our Reliance Document Control system - Support gap analysis reviews following updates to applicable regulations (FDA, CMDR, ISO 13485, EU-IVDR, etc.) **What You Bring** - Bachelor's degree in science, business, management, or a related field - 2-3 years of Quality Assurance experience in an FDA or ISO regulated environment, preferably in medical devices - 2-3 years of experience with training and auditing (internal or supplier audits) - Strong understanding of Quality Lean initiatives - Strong understanding of 21 CFR 820 and ISO 13485 (preferred) - Strong communication skills, both written and verbal, with the ability to build relationships across teams - Supervisory experience with a track record of coaching and developing others (preferred, not required) - Strong PC skills, including Microsoft Word and Excel **Work Environment** You'll work in a climate-controlled biological/chemical laboratory setting, with occasional short periods in walk-in coolers. This role requires the ability to wear lab clean-room attire and protective equipment for up to two and a half hours at a time, and involves standing, walking, and light lifting (up to 30 lbs. occasionally). Travel is estimated at up to 5% and may include customer visits, trade shows, or presentations, domestically or internationally. **Why Streck** At Streck, our values — Integrity, Creativity, Customers, Employees, Community, and Quality — guide everything we do. We're proud to offer a collaborative, growth-oriented environment where quality professionals can build meaningful careers while making a real impact on healthcare. ### Streck Offerings - A challenging, safe and rewarding work environment - No night or weekend shifts - Excellent work life balance - Market competitive pay - Comprehensive and inclusive benefits - Great team environment - On and off campus career development opportunities