Careers

Training Coordinator-GMP/ISO Training Coordinator

Corporate | Santa Ana | CA

Job Function:
We are seeking an individual to coordinate and conduct SOP, ISO 13485, & GMP training for new employees and on an on-going basis. Review training requirements for jobs and establish training requirements and proficiency standards. Track and trend human errors for re-training needs and SOP and process improvement needs. Maintain training database up to date. Ensure quality is present in all employee training functions that impact quality and are regulated by GMP, 21 CFR 820, ISO 13485, MDD 93/42/EEC, IVDD 98/79/EC, Canadian Medical Device Regulation.

 

Job Duties:

  • Incorporate corporate culture & OPEX program into new hire training program.
  • Set minimum ISO/GMP training requirements for all jobs.
  • Coordinate and conduct onboarding ISO/GMP training & ensure that procedural proficiency has been achieved and all training documentation filed with HR and Document Control as appropriate.
  • Track and trend human errors for re-training needs and SOP and process improvement needs. Coordinate re-training with department management & HR as needed, including removing an employee temporarily from their job until proficiency is achieved.
  • Maintain training database up to date including individual training records and training plans for each job.


Experience/Education:

  • A minimum of two (2) years’ experience working in a training environment and with an electronic training tracking/learning management system.
  • A minimum of six (6) years’ experience working in a medical device manufacturing environment.
  • Manufacturing and/or Quality experience, preferably both.
  • Bachelor’s degree preferred.
  • High school diploma or equivalent.
  • Extensive knowledge of current industry regulations, e.g., cGMP, 21 CFR 820, ISO 13485, Canadian Medical Device Regulations, and quality management systems
  • Working knowledge of problem solving tools and root cause analysis.
  • Working knowledge of electronic training tracking/learning management system.
  • Excellent interpersonal and communication skills.
  • Excellent English verbal and written communication skills.

 

To Apply: Please send resume to: fisiirlrecruitment@fujifilm.com. Please put Training Coordinator 120718 in the subject line.

 

Principals only. No recruiters please.

 

Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.


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