Quality Assurance Supervisor

Streck•La Vista, NE

4d•Onsite

About The Position

Streck is seeking a Quality Assurance Supervisor to lead and develop their team of QA Specialists. This role involves championing product quality and regulatory compliance, providing day-to-day coaching and technical guidance, partnering with the Quality Assurance Manager on strategic initiatives, and maintaining systems for product safety and compliance. The ideal candidate will be a quality professional who can translate regulatory complexity into practical action.

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.)