A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.
In North America we have more than 5,000 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.
Come and join a family-owned global company with a long-term vision, and a human-centered culture as a Quality Manager!
Principal Job Duties and Responsibilities:
- Performs all work in compliance with company policy and within the guidelines of the BioFire Diagnostics, LLC Quality System.
- Supervisory duties, including: time card review and approval, performance reviews, assist in skills/career development, provide motivating work environment and accurate feedback on performance, recommend/approve merit increases, promotions, hires and terminations.
- Set priorities for workload and delegation of tasks.
- Develop, maintain, and report on trends specific activities of their team. Summarize for Sr. Management.
- Appraise performance of employees against job duties, objectives and project.
- Recommend, develop and implement of Quality System policies.
- Monitor, review and track internal customer complaints and work with the Associate Director of Quality Assurance and other key stakeholders in the prompt resolution of significant quality issues.
- Supervise junior managers and supervisors.
- Interface with other department managers to communicate status, priorities and/or problems
- Training and mentoring of specialists, supervisors, and quality engineers on inspection and measurement systems
- Read, understand and interpret material specifications, test procedures, etc. and be able to write procedures in compliance with national and international standards and conventions i.e. Current Good Manufacturing Practices (cGMP's), International Standards Organization (ISO), National Institute of Standards and Technology (NIST), etc.
- Facilitate and/or lead teams with problem solving investigation methodologies and provide guidance on validation and qualification strategies for measurement systems.
- Define, document, and create work instruction procedures and technical reports utilizing GD&T methodologies and IPC standards
- Define, document, and analyze Gauge R&R studies
- Work with the Associate Director of Quality to hire appropriately, ensuring that the demands of Manufacturing, Engineering, and Materials Management are met.
- Conduct yearly QA manager employee reviews to improve team performance.
Training and Education:
- Bachelor’s Degree in life science or engineering discipline preferred. Experience in a quality, laboratory, or medical device manufacturing position at a company that has a formal quality system (e.g. ISO 9001, ISO 13485 or GMP) may substitute for a degree.
- Demonstrate experienced computer skills, including high proficiency in MS Word and Excel.
- Experience or Certification in Quality Management Systems for FDA – CFR, ISO 13485, and ISO 9001 preferred but not required.
- High-level management skills
- Expert level understanding of Quality Management Systems compliant to FDA – CFR, ISO 13485, ISO 9001, and CMDR in their area of work.
- Design, application, and use of management metrics
- Development of trends and measures
- Developing procedures for Quality Assurance and advising on compliance aspects of procedures for other groups.
- Creating and giving training presentations.
- High level written and oral communication skills.
- Ability to collaborate and interact with peers outside the QA organization.
- Application and use of Continuous Improvement and QA tools—(Pareto, flow charts, Ishikawa, process capability, histogram, facilitation techniques, etc.)