Quality Engineer

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. 00Responsible for supporting Quality Engineering requirements for new product development, legacyproduct maintenance activities, continuous improvement, risk management and customersatisfaction. Will serve as a subject matter expert and liaison between company andcustomers/vendors with the goal of resolving quality and manufacturing issues and ensuringpositive channels of communication to ensure customer satisfaction.

Duties And Responsibilities Key member of complaint and MRB investigation teams. Analyze, identify, develop andimplement manufacturing, production, and other process improvements which will improvecapability, and/or performance. Meet with appropriate teams and/or individuals to offerrecommendations and share results. Create Failure Mode and Effects Analysis (FMEA) for new and existing products based onrisk assessment and in alignment with ISO 14971: 2019. Collaborate with R&D andRegulatory department personnel to align risks identified and mitigations to reduce andcontrol risk. Quality representative for new equipment program. Evaluate new equipment for validationrequirements. Act as a reviewer/approver on equipment validations performed by otherdepartments.

Represent the company via interactions with Suppliers including new products, SupplierCorrective Action Reports, change notifications, etc. Review SCARs sent back fromsuppliers to assess corrective actions. Conduct and/or participate in supplier audits. Represent Quality on new product development teams and transition new designs intoproduction. Work closely with Operations personnel to develop strategy and plans forimplementation. Schedule and lead periodic cross-functional meetings to review the Validation Program. Recommend process/equipment candidates for re-validation based on changes tooperations, processes and practices.

Write, review, and approve validations, whennecessary, (installation qualification IQ/operational qualification, OQ/performancequalification PQ protocols, Standard Operating Procedures (SOP), technical reports, andfinal reports) for new products, processes, and equipment; ensure systems, utilities, andprocesses comply with the Food and Drug Administration (FDA) and industry standards. Participate in management review meetings and/or prepare information and trending data tobe shared in the meeting. Enable positive communication channels internally and externally to ensure the highest levelof customer satisfaction. Develop, prepare, and implement Quality Program plans for new and existing customersspecific 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 applygood 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: excellentcommunication, interpersonal skills, well developed problem-solving skills; solidorganizational skills and the demonstrated ability to be self-directed and effectively relate toall levels of the organization. Strong computer skills a must, to include Word, Excel, PowerPoint; experience with AccessDatabase is a plus. Minimum Job Requirements: Bachelor of Science degree in Quality or Mechanical Engineering orsimilar. 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 LeanManufacturing experience a plus.

Why Join Bio-TechneWe 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.