**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.** Bio-Techne’s Diagnostics Division has been providing essential products to the in vitro diagnostics industry for over 40 years. We supply quality controls and reagents for clinical laboratory and point-of-care testing, along with custom products to other companies serving the IVD market. **Position Summary:** The Quality Engineer will support both the Quality Assurance (QA) and Regulatory Affairs (RA) functions with a focus on the following: + Establishing statistical information for quality improvement + Identifying quality systems process improvements + Collecting feedback from clients to evaluate quality satisfaction + Analyzing information, applying technical understanding + Developing standards, reporting research results + Managing processes as well as manufacturing methods and procedures + Supporting innovation initiatives in conjunction with Engineering and Manufacturing Teams. The Quality Engineer supports new products being transferred into manufacturing, and must understand and apply CFR 820 guidance, cGMP and ISO standards during product and process transfers into Manufacturing. The Quality Engineer aids manufacturing in achieving their goal of producing quality products efficiently and repeatedly with robust and streamlined processes and procedures. This position closely collaborates with the Sales, Marketing, Supply Chain, Manufacturing, Manufacturing Engineering, Formulation & Filling, and Q.C. departments. **Responsibilities:** + Responsible for process risk assessment, scale-up, process improvement, and validation readiness of formulation, filling, and packaging operations. + Participate in new product introduction meetings for design review to ensure quality requirements are identified and captured in appropriate documentation. + Leads FMEA team and produce risk assessment reports for processes (pFMEA) and new products. + Review and approve validations (installation qualification IQ/operational qualification, OQ/performance qualification PQ protocols, Standard Operating Procedures (SOP), technical reports, and final reports) for new products, processes, and equipment; ensure systems, utilities, and processes comply with the Food and Drug Administration (FDA) and industry standards. + Responds to and resolves customer complaints about products. + Responsible for initial assessment and generation of Complaint Acknowledgement. + Coordinates complaint investigation with assistance of members of the CAPA/Complaint team. + Generates and shares Complaint Response. + Develop procedures to aid in streamlining and improving product quality or reducing production waste. + Performs statistical analysis to assess products. + Identifies specific problems with a product’s design or engineering. + Brainstorms new and innovative ways to increase production efficiency. + Exhibits ability to think creatively. + Actively participates in internal, customer and third-party audits. + Supports QA team during third-party or customer audits as scribe and runner. + Participates in internal audits as part of QA team. + Completes ISO 13485 internal auditor training + Assists with annual schedule of internal audits + Performs verification to ensure cGMP training requirements is met. + Provides initial training for QMS/GDP for new hires or schedules alternate. + Develop and lead training initiatives of team members as directed. + Leads Material Review Board meetings (MRB), assists with Non-Conforming Material Review (NCMR) reports + Assists with generating change requests, corrective and preventive actions (CAPA) as needed + Identify process improvement opportunities. + Devises ways to troubleshoot problems to ensure products are constructed appropriately. + Collaborates with other quality engineers and design staff to determine best production practices. + Identifies and addresses documentation deficiencies. + Ensure process/ product engineering and manufacturing activities are conducted in accordance with documented procedures, cGMP’s and applicable regulatory requirements. + Demonstrates ability to multitask + Must have the ability to manage multiple projects with minimal supervision. + Works well with a team. + Communicates clearly and effectively with others. + Demonstrates respect and collaborative spirit with both internal and external customers. + Readily able to offer opinions and take action when the position may be unpopular. + Skilled at handling situations diplomatically. + Participates in Daily Management Meetings as tier 3 representation for QA. + Can translate technical engineering language to layman’s terms for the purposes of presentations. + Follows company policies and practices as outlined in the Handbook, SOPs and SWIs and as well as follows guidelines regarding safety as outlined in the safety program and in accordance to the job function. + Manages time well and will put in extended time as needed. + Willingness to accept changes in work from day-to-day within reasonable and expected boundaries. + Perform other duties as assigned. **Qualifications:** + A Bachelor’s degree in Engineering or related field. + 3 – 5 years Process Engineering experience working on the manufacturing and production of In Vitro Diagnostics (IVDs), Medical Devices, or Pharmaceutical products. + Demonstrated knowledge of pharmaceutical formulation concepts, processes, scale-up, transfer, problem-solving, trouble-shooting, and experimental design. + Must have strong communication skills, both verbal and in writing and possess a working knowledge of analytical and process equipment, quality control systems and statistical software. + Must have strong organizational skills. + The ability to work in a collaborative way as part of a team is a must. + Basic mechanical aptitude and a good working knowledge of mechanical packaging equipment is required. + Work experience in a leadership position managing people, delegating tasks to ensure completion is strongly preferred. + Technical excellence specific to lyophilization and aseptic processing is a plus. **Why Join Bio-Techne:** **We offer competitive wages along with extensive benefits for employees and their families.** **We invest in our employees’ financial futures through retirement programs and an employee stock purchase plan.** **We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more.** **We offer an international and diverse working environment, enriched by employee resource groups; volunteer and charity events; and employee events that build a culture of caring and belonging.** **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.** **Bio-Techne is an Equal Opportunity Employer. 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.