Quality Assurance Supervisor
Summary
Supervise a team of QA Specialists in a regulated medical-device lab, ensuring products meet FDA/ISO standards and driving compliance and process improvements.
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.