Full-Time

Quality Assurance Supervisor

QMS

Streck

Streck

201-500 employees

Clinical laboratory products for accurate diagnostics

No salary listed

La Vista, NE, USA

In Person

Travel is estimated at up to 5% and may include domestic or international customer visits, trade shows, or presentations.

Bachelor's

Category
Manufacturing Quality & Test (1)
Required Skills
FDA Regulations
Word/Pages/Docs
Quality Assurance (QA)
Data Analysis
Excel/Numbers/Sheets

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Requirements
  • A bachelor's degree in science, business, management, or a related field is required.
  • Two to three years of Quality Assurance experience in an FDA- or ISO-regulated environment are required, preferably in medical devices.
  • Two to three years of experience with training and auditing, including internal or supplier audits, are required.
  • A strong understanding of Quality Lean initiatives is required.
  • A strong understanding of 21 CFR 820 and ISO 13485 is preferred.
  • Strong written and verbal communication skills and the ability to build relationships across teams are required.
  • Strong PC skills, including Microsoft Word and Excel, are required.
  • The role requires wearing laboratory clean-room attire and protective equipment for up to two and a half hours at a time, standing, walking, and occasional lifting of up to 30 pounds.
Responsibilities
  • Recruit, hire, and train Quality Assurance department employees in partnership with the Quality Assurance Manager and Human Resources.
  • Manage team schedules, timecards, paid time off, and overtime.
  • Provide supervisory leadership and guidance to Quality Assurance Specialists to ensure compliance with the Quality System and applicable regulations.
  • Conduct regular performance evaluations to motivate and develop the team.
  • Partner cross-functionally to resolve nonconformances, production issues, and process-improvement opportunities.
  • Analyze monthly Quality Assurance data to identify trends and compile quarterly metrics.
  • Develop and deliver ongoing training on the Quality System, including tools and resources for the team.
  • Support the review of Deviation and Nonconforming Reports and help identify root causes and prevention strategies.
  • Assist with internal audits and Corrective and Preventive Action follow-up with the Quality Assurance Coordinator.
  • Evaluate training practices for new hires and transfers alongside Operations Supervisors.
  • Provide Quality Assurance final approval of document revisions in the Reliance Document Control system.
  • Support gap-analysis reviews following updates to applicable regulations, including FDA, CMDR, ISO 13485, and EU-IVDR.
Desired Qualifications
  • Supervisory experience with a track record of coaching and developing others is preferred.
  • Experience in a medical-device environment is preferred.
  • Knowledge of 21 CFR 820 and ISO 13485 is preferred.

Streck makes products and solutions for clinical and research laboratories to help them deliver accurate test results. Their offerings include reagents, controls, and other lab materials used in diagnostics, helping labs advance diagnostic workflows and support better patient outcomes. The products are manufactured in La Vista, Nebraska and shipped to thousands of labs worldwide, enabling broad accessibility and consistent performance across sites. Streck differentiates itself through its long history (founded in 1971), established manufacturing base, and global reach, which together emphasize reliability, quality control, and support for diverse lab needs. The company’s goal is to enable laboratories to provide reliable results that improve diagnoses and patient health.

Company Size

201-500

Company Stage

N/A

Total Funding

N/A

Headquarters

La Vista, Nebraska

Founded

1971

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Simplify Jobs

Simplify's Take

What believers are saying

  • August 2026 HopeScan support expands Streck’s brand into global cancer diagnostics and philanthropy.
  • May 2026 product launches broaden Streck’s portfolio across sepsis, respiratory, sexual-health, and flow-QC markets.
  • Madison Industries ownership supplies capital for manufacturing scale, distribution, and product development after the 2023 acquisition.

What critics are saying

  • Most 2026 launches remain research-use-only, capping revenue and delaying clinical adoption.
  • Nebraska Supreme Court’s January 2026 appraisal ruling keeps shareholder-value litigation active around Streck.
  • DiaSorin, bioMérieux’s Accellix, and transport-media rivals can squeeze Streck’s pricing and displace accounts by 2027.

What makes Streck unique

  • Streck’s May 2026 FDA-cleared MDx-Chex controls lock into DiaSorin LIAISON PLEX blood-culture workflows.
  • CD-Chex Daily covers 51 markers, matching spectral cytometry’s complexity with one assayed vial.
  • Nucleic Acid Plus BCT stabilizes cfDNA, cfRNA, EVs, and proteins from one draw.

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Benefits

Remote Work Options

Company News

Streck
Aug 19th, 2026
Streck supports HopeScan Initiative with charitable donation to expand access to cancer diagnostics in West Africa.

Streck supports HopeScan Initiative with charitable donation to expand access to cancer diagnostics in West Africa. August 19, 2026 LA VISTA, Neb., and UPPER MARLBORO, Md. - Streck, a leader in sample stabilization and quality control solutions for clinical and research laboratories, has made a charitable donation to HopeScan Initiative, Inc. HopeScan is a U.S.-based 501(c)(3) nonprofit working to expand access to cancer screening, diagnostic services and care in underserved communities across sub-Saharan West Africa. The donation will support HopeScan's efforts to strengthen access to diagnostic services and help connect communities with pathways to appropriate follow-up care. The contribution reflects a shared belief that advances in diagnostic technology should have the opportunity to benefit patients and communities regardless of geography or access to healthcare resources. "Streck is proud to support HopeScan's mission to expand access to next-generation diagnostic testing in underserved communities," said Dara Wright, Chief Executive Officer and President, Streck. "We believe broader access to innovative diagnostic technologies has the potential to provide clinicians with valuable insights and, ultimately, help improve the lives of patients and their communities." For more than 50 years, Streck has developed technologies designed to preserve sample integrity and support reliable laboratory testing. Its blood collection and stabilization technologies are used in research and clinical workflows around the world, including applications supporting the rapidly evolving fields of liquid biopsy and molecular diagnostics. HopeScan works with healthcare providers and communities to address barriers that can limit access to cancer screening and diagnostic services. Streck's contribution will help advance HopeScan's work in West Africa and support its broader mission of bringing advances in cancer diagnostics to communities where access remains limited. "We are incredibly grateful to Streck for its generous financial contribution, which will help expand access to cervical cancer screening and care in Nigeria," said Dr. Omoshile Clement, Executive Director of HopeScan Initiative Inc. "By supporting the purchase of HPV DNA testing and patient specimen collection kits, Streck is helping us reach more women with the opportunity for early detection and timely care - an important step toward reducing the burden of cervical cancer in underserved communities." About Streck Established in 1971, Streck provides solutions that ensure every result counts by empowering clinical and research laboratories to reliably deliver accurate results, advance diagnostics, and enable healthier, happier lives for patients everywhere. Streck products are manufactured in La Vista, Nebraska, and delivered to thousands of labs worldwide. About HopeScan Initiative, Inc. HopeScan Initiative, Inc. is a 501(c)(3) nonprofit organization advancing equitable access to cancer awareness, early detection, confirmatory diagnosis, and navigated care in underserved communities across sub-Saharan West Africa. Through partnerships with trusted cancer specialists, hospital networks and local community engagement, HopeScan helps bridge the gap between disease onset and care by supporting early screening, diagnostic confirmation, patient navigation, treatment referral, and follow-up care. Initially focused on breast, cervical, and prostate cancers, HopeScan is committed to building sustainable pathways to prevention and care as well as strengthening local capacity so that access to life-saving cancer detection and treatment are not determined by geography or socioeconomic status. Learn more at hopescan-initiative.org.

CAP Today
May 19th, 2026
Streck gets IVD clearance for MDx-Chex controls, launches blood culture tube.

Streck gets IVD clearance for MDx-Chex controls, launches blood culture tube. May 19, 2026 - Streck has received in vitro diagnostic clearance for three MDx-Chex controls for sepsis testing. MDx-Chex for BCY, MDx-Chex for BCP, and MDx-Chex for BCN are patient-like, ready-to-use, full-process molecular quality controls designed for verification of the Diasorin Liaison Plex yeast, Gram-positive, and Gram-negative blood culture assays, respectively. The controls are supplied in 10 single-use vial kits and feature room temperature storage. In a separate release, Streck announced the launch of its Nucleic Acid Plus BCT blood collection tube. Formerly known as Protein Plus BCT, this product has expanded its intended use claims to include cell-free DNA, cell-free RNA, extracellular vesicles, and select plasma proteins in an aim to better suit downstream multianalyte applications. Nucleic Acid Plus BCT provides stabilization of whole blood samples at ambient temperature (18°-25°C), with cfDNA and cfRNA remaining stable in stored samples for up to seven days and EVs and select plasma proteins remaining stable for up to five days. This allows for multianalyte analysis from a single draw. The tube's proprietary preservative reagent stabilizes nucleated blood cells, red blood cells, and platelets while minimizing ex vivo hemolysis and platelet activation. Nucleic Acid Plus BCT is for research use only and available as a 5-mL configuration in packs of six, boxes of 100, or cases of 1,000. A 10-mL configuration is expected to launch later this year.

Streck
May 4th, 2026
Streck's CD-Chex(TM) Daily delivers 51-marker coverage in a single, assayed vial for standardized flow cytometry QC.

Streck's CD-Chex(TM) Daily delivers 51-marker coverage in a single, assayed vial for standardized flow cytometry QC. May 4, 2026 La Vista, Nebraska - Streck is pleased to announce the launch of CD-Chex(TM) Daily, the newest addition to the CD-Chex line of flow cytometry quality controls. CD-Chex Daily is a ready-to-use, assayed quality control designed to simplify and modernize daily QC workflows for flow cytometry laboratories. CD-Chex Daily provides comprehensive coverage across 51 markers in a single vial, with markers spanning surface, intracellular and leukocyte scatter populations, including CD200, TRBC1, cMPO, CD27, CD81, CD79b CD36, cCD79a, CD79b, cKappa, cLambda and more, for broad panel support. CD-Chex Daily supports modern high-volume spectral cytometers and integrates seamlessly with Streck's STATS(R) interlaboratory QC Program. The control's standardized assayed ranges meet CAP, CLIA, CLSI, and ISO 15189 requirements, limiting reliance on fragmented QC methods and supporting consistent comparability across instruments and overtime. ""Labs have been asking for a single control that keeps pace with complex panels and modern instrumentation," said Mirta Gamez, MT(ASCP), CLS, Associate Director of Hematology. "CD-Chex Daily delivers that - reducing costs, minimizing variability, and supporting compliance from day one." Supplied in a 3.0 mL pierceable plastic vial, available in single (Cat. No. 230695), two-pack (Cat. No. 230696), and five-pack (Cat. No. 230697) configurations, CD-Chex Daily provides 90-day closed-vial and 30-day open-vial stability to support labs of all testing volumes. CD-Chex Daily is for Research Use Only. Not for use in diagnostic procedures. About Streck, Inc. Established in 1971, Streck provides solutions that ensure every result counts by empowering clinical and research laboratories to reliably deliver accurate results, advance diagnostics and enable healthier, happier lives for patients everywhere. Streck products are manufactured in La Vista, Nebraska, and delivered to thousands of labs worldwide.

SelectScience
Aug 18th, 2025
Streck launches new MDx-Chex controls for molecular diagnostic assays

Streck launches new MDx-Chex controls for molecular diagnostic assays.

PR Newswire
Jun 3rd, 2025
Streck Releases Improved Arm-D® Kit, Oxa With Expanded Coverage In Three New Oxa Gene Families

LA VISTA, Neb., June 3, 2025 /PRNewswire/ -- Streck is excited to announce the release of an updated version of the Streck ARM-D® Kit, OXA that detects an additional 36 allelic variants in 3 new antimicrobial resistance (AR) gene families. This expanded coverage is in response to customer feedback, particularly the member laboratories of the Antimicrobial Resistance Laboratory Network (ARLN) and the Centers for Disease Control and Prevention (CDC), who have identified gene families and allelic variants of increasing diversity and relevance and require a surveillance method that can effectively detect them. Of particular interest to these labs is effective detection of the variants of OXA-235, OXA-236 and OXA-237 in the OXA-134 family, as well as OXA-327-like and OXA-198-like beta-lactamase enzymes."The expansion of the Streck ARM-D Kit, OXA demonstrates our dedication to ensuring our products meet the needs of our customers in public health laboratories and emphasizes our commitment to make a global impact through solutions that improve infectious disease testing strategies," said Chris Connelly, director of Business Segment – Molecular. "We're proud to be a trusted resource for laboratories working hard in the fight against antimicrobial resistance."Streck's ARM-D kits allow for the cost-effective and comprehensive detection of more than 2,000 allelic variants across 25 AR gene families. Results from the kits demonstrate 100% concordance with whole genome sequencing (WGS) data from the same samples, for the targeted AR variants. The ARM-D kits are often used as a pre-WGS screening method to reduce the cost of AR surveillance in public health laboratories in the United States and other parts of the world.Streck ARM-D Kit, OXA is For Research Use Only