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Quality Manager/Senior Quality Manager-Document Control and Training

Cette offre d'emploi n'est plus active.

Localisation: Salt Lake City, UT, États-Unis
Type de Contrat: Fixed-Term
Fonction: Quality

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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.



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