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Quality Manager/Senior Quality Manager-Document Control and Training

Location: Salt Lake City, UT, United States
Position Type: Fixed-Term
Job Function: Quality

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

Description

Principal Job Duties and Responsibilities:

  1. Performs all work in compliance with company policy and within the guidelines of the BioFire Diagnostics, LLC Quality System.
  2. 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.
  3. Set priorities for their team and delegate tasks to balance workloads.
  4. Develop, maintain, and report on trends specific activities of their team. Summarize for Sr. Management.
  5. Appraise performance of employees against job duties, objectives and project.
  6. Recommend, develop and implement of Quality System policies.
  7. Interface with other department managers to communicate status, priorities and/or problems
  8. Assist Quality Technicians and Specialists to ensure that required documents and records are approved and stored in compliance with applicable regulations and standards.
  9. Work with the Director of Quality to hire appropriately, ensuring that the demands of all departments and project timelines can be met.
  10. Conduct yearly employee reviews to improve team performance
  11. Collaborate with internal software teams to enhance and maintain electronic document control and training management systems.
  12. Identify improvements to document control and training procedures to improve efficiency while maintaining compliance.
  13. Work with other departments to find solutions to unique document control situations issues.
  14. Support audit teams as a subject matter expert on document control and training procedures and records.
  15. Develop training strategies to ensure mandatory training is completed on time and to enhance Quality System understanding across the company.

 

Training and Education: 

  1. 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.
  2. Demonstrated experienced computer skills, including high proficiency in MS Word and Excel.
  3. Experience or Certification in Quality Management Systems for FDA – CFR, ISO 13485, and ISO 9001 preferred but not required.

Experience: 

  1. Previous experience working with document control and training management systems in a regulated industry
  2. Demonstrated results leading and managing teams to improved performance
  3. Expert level understanding of Quality Management Systems compliant to FDA – CFR, ISO 13485, ISO 9001, and CMDR in their area of work
  4. Design, application, and use of management metrics

Skills:  

  1. Development of trends and measures
  2. Developing procedures for Quality Assurance and advising on compliance aspects of procedures for other groups. 
  3. Creating and giving training presentations.
  4. High level written and oral communication skills.
  5. Ability to collaborate and interact with peers outside the QA organization.



BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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