By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Pay Range:

$62,300.00 - $102,350.00

Position Summary: The Software Quality Specialist will be a key member of Bio-Techne’s Asuragen Quality Assurance team and will partner with both the Regulatory Affairs and Diagnostic Software and Bioinformatics Teams to ensure software products comply with internal processes, applicable guidelines, and regulations (e.g., IEC 62304, AAMI TIR34, FDA and IVDR).

Key Responsibilities:

· Serve as Quality Assurance representative on project core teams developing new and updated software products.

· Support the Complaint Management Process through the review and investigation of software related customer complaints.

· Partner with Regulatory Affairs on software deliverables required to register or maintain registration of IVD software products.

· Work with Asuragen’s Diagnostic Software and Bioinformatics Teams to ensure new software products comply with internal processes, applicable guidelines, and regulations (e.g., IEC 62304, AAMI TIR34, and FDA).

· Ensure that software development process documents are complete, accurate, and finalized in a timely manner.

· Provide your software expertise and knowledge to the Quality Assurance team during software system validation projects and root-cause investigations.

· Apply established risk-based approaches in accordance with BS ISO 14971:2022, EU 2017/746, and other applicable regulations and standards.

· Support internal and external Quality System audits as a software quality subject matter expert.

· Monitor new and revised software regulations and standards to help keep Asuragen’s software development programs up to date.

Education and Experience:

Minimum of 2 years experience in a Quality Assurance or Software Development role in an IVD manufacturing environment. Bachelor’s degree in a related field from an accredited college or university, or equivalent experience in Quality Assurance.

Knowledge, Skills, and Abilities:

· Excellent written and oral communication skills.

· Demonstrated success working on cross-functional teams.

· Results-driven with demonstrated ability to find solutions to achieve company goals in an effective, efficient manner.

· Able to flourish in a fast-paced, multi-tasking and dynamic environment.

· Able to build strong relationships across a wide spectrum of internal and external parties.

· CSQE certification a plus

· Familiarity with molecular in vitro diagnostic (IVD) assays and devices

Why Join Bio-Techne

We have an incredibly talented group of down-to-earth professionals with the experience, drive and creativity that makes Bio-Techne a world-class global diagnostics company. Our workplace is full of enthusiastic, hardworking, and intelligent people with bold ideas and the determination to see them through.

Our best-in-class reagents, instrument, custom manufacturing, and diagnostic tests are used throughout a patient’s lifespan by laboratories worldwide. Bio-Techne has locations in Minneapolis, MN, Austin, TX, Boston, MA, Denver, CO and San Jose, CA and all sites offer top-notch technology, educational, and business benefits. Science is our passion; it drives us to collaborate, develop and manufacture award-winning tools that help researchers achieve reproducible and consistent results.

Bio-Techne provides a competitive salary, medical, dental, disability and life insurance, a 401(k) plan with company matching, an employee bonus plan, and a tuition reimbursement plan. We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. 

Bio-Techne is an E-Verify Employer in the United States.

Why Join Bio-Techne:

We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.We invest in our employees’ financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging. We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

Bio-Techne is an E-Verify Employer in the United States.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.