Streck is a Nebraska based biotechnology company that makes a global impact by developing and distributing to labs worldwide. Our products provide confidence for accurate health care testing!

Our passions and priorities are focused on taking care of our customers, employees, and giving back to our community. Streck has jobs for every stage of your career. If you are a dependable, hard-working, and team-oriented individual who values meaningful work, Streck is looking for you to join our community of passionate people on a mission!

Our Quality Assurance team is looking for people who are driven to solve problems and collaboratively share ideas for process improvement while utilizing your analytical skills.

The primary responsibilities include:

Ensure compliance of the entire Quality System to all applicable international regulatory requirements, including FDA QSR, ISO 13485, Canadian Medical Device Regulations, and EU regulations.
Plan and develop structure for future transitions and enhancements to the QMS.
Review and approve protocols, deviations, CAPAs, Change Control procedures as the subject matter expert, as well as, in the capacity of a quality assurance reviewer.
Lead and participate in CAPA programs, ensuring suitability, implementation and effectiveness.
Manage and assure regulatory compliance of the Document Control system.
Coordinate, host and prepare corporate response to inspections / audits by all regulatory agencies (FDA, ISO, CMDR) and customer accounts.

Requirements include:

Bachelor’s degree in science or STEM field.
Minimum three to five years supervisory/managerial experience required.
Five years of experience in Quality Assurance in regulated environment (ISO, medical device, etc) preferred.
Minimum of three to five years of auditing experience, leading internal / supplier audits.

Streck provides:

Challenging, Safe and Rewarding Work Environment
No nights, no weekends, or on-call
Work-Life Balance
Affordable, high-quality apartments for employees
Competitive Pay
Comprehensive and Inclusive Benefits
Great Team Environment
On and off campus professional development training opportunities

Visit www.streckcareers.com to learn more about Streck and apply for this opportunity.

Streck develops and delivers quality control and diagnostic products that help stabilize and validate the samples and tests for researchers, laboratories, hospitals and clinicians all over the world.

Streck is located in a state-of-the art facility just minutes from Interstate 80 in the southwest Omaha/LaVista area. We offer a collaborative environment with career advancement opportunities, competitive pay, comprehensive benefits, work/life balance and corporate wellness focus.

Streck is an Equal Opportunity/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.