Quality Assurance Supervisor: Lead & Develop Medical QA Team

Streck, Inc.; La Vista (NE); On-site; USD 80,000 - 110,000; Full time

Job summary

Streck, a Nebraska-based manufacturing company, seeks a Quality Assurance Supervisor to lead and develop a team of QA Specialists, championing product quality and regulatory compliance across the organization.

You'll provide day-to-day coaching, partner with the QA Manager on strategic initiatives, and help maintain systems ensuring safe, compliant, and best-in-class products. This role requires 2–3 years in FDA/ISO QA, training/auditing, and strong Lean/regulatory knowledge.

Qualifications

• 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.

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.)

Skills

Quality Assurance

Training & Auditing

Communication

Supervisory Experience

Lean Principles

Regulatory Knowledge

Microsoft Word/Excel

Education

Bachelor's degree in science, business, management, or related field

Tools

Microsoft Word

Microsoft Excel

Job description

Streck, a Nebraska-based manufacturing company, seeks a Quality Assurance Supervisor to lead and develop a team of QA Specialists, championing product quality and regulatory compliance across the organization.

You'll provide day-to-day coaching, partner with the QA Manager on strategic initiatives, and help maintain systems ensuring safe, compliant, and best-in-class products. This role requires 2–3 years in FDA/ISO QA, training/auditing, and strong Lean/regulatory knowledge.