At BioFire Diagnostics, LLC. we make the world a healthier place by providing molecular solutions that lessen the time to medical results and empower healthcare professionals to make better diagnostic decisions.
We are proud to be part of the bioMérieux family and the 5,000+ team members across 12 sites and subsidiaries in North America committed to our mission to help save lives around the globe through the power of diagnostics.
Come be a part of our team and our mission as a Quality Manager!
This is a full-time exempt position that is responsible for leading complex teams to support the functions of BioFire’s Quality Management System. The person is an excellent personnel manager that is also responsible for identifying and analyzing trends in productivity and quality with reliance on extensive technical experience and judgment to plan and accomplish goals as well as supporting problem resolution.
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 metrologists and incoming materials inspection team on metrology and measurement systems
- Work with Engineering to define metrology tools as well as design and implement measurement systems for incoming materials
- Read, understand and interpret equipment specifications, test procedures, etc. and be able to write procedures that outline the calibration and maintenance of Measurement & Test Equipment 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.
- Lead raw material SPC analysis program and on-going development of statistically based reviews
- Facilitate and/or lead teams with problem solving investigation methodologies and provide guidance on validation and qualification strategies for measurement systems.
- 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.
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 as demonstrated by success at Quality Manager II
- 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.
- Previous experience on similar teams and/or Manager II.
- Development of trends and measures
- Developing procedures for Quality Assurance and advising on compliance aspects of procedures for other groups. Providing motivation for team members to follow procedures.
- 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, 8D, etc.) a plus.
Must be able to lift at least 25 lbs and may be required to lift up to 50 lbs. Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation.