**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: $73,100.00 - $120,200.00 Responsible for supporting Quality Engineering requirements for new product development, legacy product maintenance activities, continuous improvement, risk management and customer satisfaction. Will serve as a subject matter expert and liaison between company and customers/vendors with the goal of resolving quality and manufacturing issues and ensuring positive channels of communication to ensure customer satisfaction. Duties and Responsibilities: · Key member of complaint and MRB investigation teams. Analyze, identify, develop and implement manufacturing, production, and other process improvements which will improve capability, and/or performance. Meet with appropriate teams and/or individuals to offer recommendations and share results. · Create Failure Mode and Effects Analysis (FMEA) for new and existing products based on risk assessment and in alignment with ISO 14971:2019. Collaborate with R&D and Regulatory department personnel to align risks identified and mitigations to reduce and control risk. · Quality representative for new equipment program. Evaluate new equipment for validation requirements. Act as a reviewer/approver on equipment validations performed by other departments. · Represent the company via interactions with Suppliers including new products, Supplier Corrective Action Reports, change notifications, etc. Review SCARs sent back from suppliers to assess corrective actions. Conduct and/or participate in supplier audits. · Represent Quality on new product development teams and transition new designs into production. Work closely with Operations personnel to develop strategy and plans for implementation. · Schedule and lead periodic cross-functional meetings to review the Validation Program. Recommend process/equipment candidates for re-validation based on changes to operations, processes and practices. Write, review, and approve validations, when necessary, (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. · Participate in management review meetings and/or prepare information and trending data to be shared in the meeting. · Enable positive communication channels internally and externally to ensure the highest level of customer satisfaction. · Develop, prepare, and implement Quality Program plans for new and existing customers specific to validation and qualification activities. · Author new or revised SOPs per the QMS while ensuring consistency of processes, verbiage and taking into consideration personnel in each functional area. Act as a signatory in Change Control when necessary. · Actively participate in internal, customer, and third-party audits. · Other duties as assigned. Knowledge, Skills and Abilities Required: · Manage time wisely and effectively prioritize multiple competing tasks. · Ability to identify and solve problems, develop innovate solutions, act decisively and apply good judgement. · Readily able to offer opinions and take action when the position may be unpopular. · Skilled at handling situations diplomatically. · Proven team player who has demonstrated capabilities in the following areas: excellent communication, interpersonal skills, well developed problem-solving skills; solid organizational skills and the demonstrated ability to be self-directed and effectively relate to all levels of the organization. · Strong computer skills a must, to include Word, Excel, PowerPoint; experience with Access Database is a plus. Minimum Job Requirements: Bachelor of Science degree in Quality or Mechanical Engineering or similar. Minimum 5 years’ experience as a Quality Engineer in a manufacturing environment. Diagnostics, pharmaceutical or Biological products manufacturing environment is preferred. Proficient in understanding and application of ISO13485. Auditing, Six Sigma and Lean Manufacturing experience a plus. **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.