Advanced Quality Assurance Specialist - ISO13485

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: $55,600.00 - $91,450.00 Position Summary: The Advanced Quality Assurance Specialist will work closely with internal colleagues as a key member of the Quality Assurance team working to maintain and grow Asuragen’s Quality Management System in alignment with international quality and regulatory standards. Working knowledge of ISO 13485 is required. This role is on a hybrid schedule based out of our site in Austin, TX. 3 days onsite, 2 days remote. Key Responsibilities: Provides support ensuring compliance with all regulatory standards, systems, procedures, and practices. Includes ISO 13485, FDA QSR, MDSAP, IVDR, and other requirements relating to Quality Assurance activities: Manages supplier quality from the perspective of supplier adds, removals, validation, qualification, classification, audits, and evaluation. Assists in internal and external audits and resultant findings resolutions Assists in the execution of Document Control, Training, NCR, CAPA, Complaints and OOS systems. May be responsible for the management of one or more of these systems. Reviews and approves quality equipment calibrations and maintenance. Supports the overall Quality goals and QA Department goals. Generates metrics in support of Quality Management Reviews. Other duties as assigned. Education and Experience: Bachelors/Masters degree in a related field from an accredited four-year college or university, 4-6 years of experience in a regulated manufacturing facility; or a combination of educational and applicable work experience. Knowledge, Skills, and Abilities: Skilled in the use of software programs such as Microsoft Office and database management programs. Detail oriented and skilled at examining documents for accuracy and completeness. Ability to prepare records in accordance with detailed instructions. Knowledgeable in QA principles and concepts in a dynamic manufacturing facility Ability to set priorities and meet deadlines on a personal level. Ability to work under tight deadlines. Capability to effectively train employees on procedures, processes, and QA concepts. Team oriented individual with the ability to work effectively with multiple skill level employees. Skilled at dispute resolution. Excellent written and oral communication skills. Excellent analytical and problem-solving skills with the ability to work independently with minimal supervision. Familiarity with statistical tools and concepts and their application in a regulated environment. Knowledge of cGMP, ISO 13485, MDSAP, IVDD/IVDR and FDA QSR. 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. Bio-Techne empowers researchers in Life Science and Clinical Diagnostics by providing high-quality reagents, instruments, custom manufacturing, and testing services. Our family of brands creates a unique portfolio of products and services. Science is our passion; it drives us to collaborate, develop, and manufacture award-winning tools that help researchers achieve reproducible and consistent results.

Salary : $55,600 - $91,450