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
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 their team and delegate tasks to balance workloads.
- 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.
- Interface with other department managers to communicate status, priorities and/or problems
- Assist Quality Technicians and Specialists to ensure that required documents and records are approved and stored in compliance with applicable regulations and standards.
- Work with the Director of Quality to hire appropriately, ensuring that the demands of all departments and project timelines can be met.
- Conduct yearly employee reviews to improve team performance
- Collaborate with internal software teams to enhance and maintain electronic document control and training management systems.
- Identify improvements to document control and training procedures to improve efficiency while maintaining compliance.
- Work with other departments to find solutions to unique document control situations issues.
- Support audit teams as a subject matter expert on document control and training procedures and records.
- Develop training strategies to ensure mandatory training is completed on time and to enhance Quality System understanding across the company.
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.
- Demonstrated 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.
- Previous experience working with document control and training management systems in a regulated industry
- Demonstrated results leading and managing teams to improved performance
- 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.