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!
The Quality Manager is responsible for ensuring that our internal and external audit requirements are met, and that necessary actions within the quality system to support problem resolution such as continuous improvement and CAPA are completed on time.
The quality manager supports the employees in their team with train and mentoring. Quality Managers are expected to seek and obtain management training and improve their management skills. They are responsible for identifying and analyzing trends in productivity, quality, and relies on extensive experience and judgement to plan and accomplish goals. Performs a variety of tasks.
Essential Job Duties and Responsibilities
- Perform all work in compliance with company policy and within the guideline of BioFIre Diagnostics’ Quality System
- Supervisory duties, including: time card review and approval, performance reviews, assist in sills/career development, provide motivating work environment and accurate feedback on performance, recommend/approve merit increases, promotions, hires and terminations.
- Monitor workload and delegation of tasks.
- Maintain, and report on trends specific activities of their team.
- Appraise performance of employees against job duties, objectives and projects.
- Assist with the development and implementation 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.
- Interface with other department managers to communicate status, priorities and/or problems
- Performs other duties as assigned.
This is a mid-level position within the company and an entry-level position in management. The employees are expected to understand the role of their team and activities of team members.
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
- Required – Training in Quality Management Systems for FDA-CFR, ISO 13485, and ISO 9001.
- Previous experience in Quality Assurance or Quality Control equivalent to mastering responsibilities of a Quality Supervisor is preferred.
- Expert level understanding of Quality Management Systems compliant to FDA – CFR, ISO 13485, and ISO 9000, in their area of work.
- Application and use of management metrics preferred.
- Previous experience in similar roles in QMS related activities preferred.
Knowledge, Skills and Abilities
- Use of an reporting with trends and measures
- Understanding and following procedures. 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
- 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.
- Ability to perceive and distinguish colors.
- Must be able to travel (if necessary).