Quality & Technical Affairs Manager

Make an Impact in Medical Diagnostics

Do you like solving technical problems, working with customers, analyzing data, and making sure products meet quality standards?

KRONUS is a small, well established in vitro diagnostic (IVD) company providing test kits that support the diagnosis of autoimmune diseases to clinical laboratories and healthcare professionals throughout North America.

Job Overview

KRONUS is seeking a hands-on Quality & Technical Affairs Manager to join our team in Star, Idaho. This cross-functional role combines laboratory science, quality control and assurance, customer technical support, quality systems, and regulatory affairs.

You will oversee activities related to product quality, laboratory operations, customer technical support, complaint and Corrective and Preventive Action (CAPA) management, and regulatory support.

Reporting to the Head of Operations, you will work independently and collaborate with other members of the KRONUS team. You will track product quality, communicate directly with customers on technical matters, evaluate technical data, and contribute to regulatory projects.

This position is particularly well suited to someone who enjoys variety, problem-solving, and taking ownership of their work.

Responsibilities

Quality Control & Quality Assurance

• Manage daily laboratory operations, including instrument calibration, ordering laboratory supplies, and maintaining a clean and organized work environment.
• Plan, coordinate, and manage routine quality control activities for KRONUS’ products.
• Review and analyze QC data and documentation provided by suppliers.
• Approve QC acceptance and release of products from quarantine in accordance with applicable SOPs, prior to final approval for distribution.
• Coordinate and manage proficiency programs.
• Assist with designing and performing testing to evaluate product performance, characteristics, and stability.

Complaint & CAPA Management

• Manage the handling, investigation, and documentation of customer complaints related to product performance, safety, and effectiveness.
• Maintain and manage the Corrective and Preventive Action (CAPA) system.
• Assist in identifying nonconformities, root causes investigations, and determining appropriate corrective and preventive actions.
• Support implementation and documentation of quality improvements, including updates to procedures and other controlled documents.

Technical Support

• Provide technical information and troubleshooting assistance to current and prospective customers.
• Support sales and marketing activities by providing scientific and technical information.
• Contribute scientific expertise to projects involving the evaluation of new and existing suppliers and products.

Regulatory Support

• Assist with FDA submission activities, including product testing, data analysis, technical reporting, and preparation of regulatory documents and communications.
• Support the development and maintenance of SOPs and other internal quality documents.
• Assist in preparing documentation and data for internal and external audits.

Experience and Skills

Required

• Bachelor's degree in biology, microbiology, clinical laboratory science, or a related discipline.
• Strong written and verbal communication skills in English.
• Ability to work independently while collaborating effectively with colleagues.
• Strong organizational skills and attention to detail.
• Ability to analyze technical information and apply sound scientific judgment.

Preferred Experience

• Experience in a clinical or analytical laboratory setting or other regulated environment, preferably with familiarity with ISO 13485, ISO 17025, or CLIA.
• Experience with complaint, nonconformance, or CAPA investigations.
• Experience with technical writing, documentation, and preparation or review of technical reports.
• Experience troubleshooting immunoassays or other testing methods.