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:

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.