Quality Assurance Supervisor, Medical Devices

Streck, LLC; La Vista (NE); On-site; USD 75,000 - 105,000; Full time

Benefits offered by this job

A challenging,safeand rewarding work环境

No night or weekend shifts

Excellent work life balance

Market competitive pay

Comprehensive and inclusive benefits

Great teamenvironment

On and off campus career development机会

Job summary

Streck is seeking a Quality Assurance Supervisor in Nebraska to lead and develop a team of QA Specialists, championing product quality and regulatory compliance across the organization.

You will provide day-to-day coaching, collaborate with the QA Manager on strategic initiatives, and help maintain systems that keep products safe, compliant, and best-in-class.

Qualifications

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

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
• 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

Communication skills

Microsoft Word

Microsoft Excel

Quality Lean initiatives

Regulatory knowledge (FDA/ISO)

Supervisory experience

Education

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

Tools

Microsoft Word

Microsoft Excel

Job description

About Streck:Streck is aNebraska-basedmanufacturing company that makes a global impactbydeveloping anddistributing tolabs worldwide. Ourproductsprovide confidenceforaccuratehealth caretesting!Ourpassions andpriorities are focusedontaking care ofour customers,employees,andgiving back to ourcommunity. Streck has jobsfor every stage ofyourcareer.If you are a dependable, hard-working, and team-oriented individual who values meaningful work, Streck is looking for youto join ourcommunity of passionate people on amission!

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,safeand rewarding work environment
• No night or weekend shifts
• Excellent work life balance
• Market competitive pay
• Comprehensive and inclusive benefits
• Great teamenvironment
• On and off campus career development opportunities

Visitwww.streckcareers.comto learn more about Streck and apply for this opportunity.

Streck is an EqualEmploymentOpportunityEmployer/Individuals with Disabilities & Protected Veterans/Affirmative Action employer and forbids discrimination against any employee or applicant because of race, color, religion, gender (including pregnancy, gender stereotyping and caregiver status), sexual orientation, gender identity, transgender status, national origin, disability, genetic information, citizenship, marital status or status as a covered veteran in accordance with applicable federal, state and local laws.