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.

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Pay Range:

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$73,100.00 - $120,200.00

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Responsible for supporting Quality Engineering requirements for new product development, legacy

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product maintenance activities, continuous improvement, risk management and customer

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satisfaction. Will serve as a subject matter expert and liaison between company and

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customers/vendors with the goal of resolving quality and manufacturing issues and ensuring

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positive channels of communication to ensure customer satisfaction.

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Duties and Responsibilities:

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· Key member of complaint and MRB investigation teams. Analyze, identify, develop and

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implement manufacturing, production, and other process improvements which will improve

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capability, and/or performance. Meet with appropriate teams and/or individuals to offer

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recommendations and share results.

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· Create Failure Mode and Effects Analysis (FMEA) for new and existing products based on

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risk assessment and in alignment with ISO 14971:2019. Collaborate with R&D and

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Regulatory department personnel to align risks identified and mitigations to reduce and

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control risk.

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· Quality representative for new equipment program. Evaluate new equipment for validation

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requirements. Act as a reviewer/approver on equipment validations performed by other

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departments.

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· Represent the company via interactions with Suppliers including new products, Supplier

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Corrective Action Reports, change notifications, etc. Review SCARs sent back from

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suppliers to assess corrective actions. Conduct and/or participate in supplier audits.

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· Represent Quality on new product development teams and transition new designs into

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production. Work closely with Operations personnel to develop strategy and plans for

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implementation.

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· Schedule and lead periodic cross-functional meetings to review the Validation Program.

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Recommend process/equipment candidates for re-validation based on changes to

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operations, processes and practices. Write, review, and approve validations, when

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necessary, (installation qualification IQ/operational qualification, OQ/performance

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qualification PQ protocols, Standard Operating Procedures (SOP), technical reports, and

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final reports) for new products, processes, and equipment; ensure systems, utilities, and

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processes comply with the Food and Drug Administration (FDA) and industry standards.

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· Participate in management review meetings and/or prepare information and trending data to

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be shared in the meeting.

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· Enable positive communication channels internally and externally to ensure the highest level

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of customer satisfaction.

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· Develop, prepare, and implement Quality Program plans for new and existing customers

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specific to validation and qualification activities.

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· 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.

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Knowledge, Skills and Abilities Required:

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· Manage time wisely and effectively prioritize multiple competing tasks.

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· Ability to identify and solve problems, develop innovate solutions, act decisively and apply

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good judgement.

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· Readily able to offer opinions and take action when the position may be unpopular.

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· Skilled at handling situations diplomatically.

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· Proven team player who has demonstrated capabilities in the following areas: excellent

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communication, interpersonal skills, well developed problem-solving skills; solid

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organizational skills and the demonstrated ability to be self-directed and effectively relate to

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all levels of the organization.

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· Strong computer skills a must, to include Word, Excel, PowerPoint; experience with Access

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Database is a plus.

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Minimum Job Requirements: Bachelor of Science degree in Quality or Mechanical Engineering or

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similar. Minimum 5 years' experience as a Quality Engineer in a manufacturing environment.

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Diagnostics, pharmaceutical or Biological products manufacturing environment is preferred.

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Proficient in understanding and application of ISO13485. Auditing, Six Sigma and Lean

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Manufacturing experience a plus.

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Why Join Bio-Techne:

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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.

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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.

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We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.

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We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.

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We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.

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We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

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

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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.

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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.

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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.

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Science is our passion; it drives us to collaborate, develop, and manufacture award-winning tools that help researchers achieve reproducible and consistent results.