Quality Assurance Supervisor
Streck, LLC•La Vista, NE
•Onsite
About The Position
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.
Requirements
- 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 communication skills, both written and verbal, with the ability to build relationships across teams
- Strong PC skills, including Microsoft Word and Excel
Nice To Haves
- Strong understanding of 21 CFR 820 and ISO 13485
- Supervisory experience with a track record of coaching and developing others
Responsibilities
- 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.)
Benefits
- Comprehensive and inclusive benefits
- On and off campus career development opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
