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 change control, continuous improvement, and customer complaints handling and satisfaction. Will serve as a subject matter expert and liaison between company and customers 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.
• Responsible for change control process, perform risk assessment and facilitate the change control plan writing and execution. Monitor change implementation process and close change plan in a timely manner.
• Responsible for implementation and validation of a new electronic Quality Management System.
• Prepare quality information and trending data to be shared in the management review meeting.
• Enable positive communication channels internally and externally to ensure the highest level of customer satisfaction.
• Actively participate in internal, customer, and third-party audits.
• Other duties as assigned.

Minimum Job Requirements:

• Bachelor of Science degree in Quality, Biology, Chemistry or similar. 
• Minimum 2 years’ experience as a Quality professional 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.

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.