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Analyst 1 Quality Systems

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Job Description


AMO Manufacturing USA, LLC, a member of the Johnson and Johnson family of companies is recruiting for an Analyst 1, Quality Systems.


At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That’s why, through our operating companies, we’ve developed solutions for every stage of life—to help people see better, connect better and live better. We partner with eye care professionals to provide some of the world’s leading products and technologies to address refractive error, cataracts, dry eye, and beyond. We are committed to using our reach and size for good, and strive to put quality eye care within reach of everyone, everywhere. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.


The Analyst 1, Quality Systems is responsible for maintaining and monitoring the company's Training & document control activities in accordance with FDA/QSR, ISO 13485 requirements and other international regulations.

 

Key Responsibilities:

  • Record keeping and training documentation, including the computerized employee training and tracking system.
  • Implementing the processes and procedures as outlined in the Training management system.
  • Coordinating and supporting new hire and annual training for site associates per guidance provided by management.
  • Maintaining and monitoring the company's training activities in accordance with FDA/QSR, ISO 13485 requirements and other international regulations
  • Supports development of new training modules that are critical to JJSV employee training.
  • Assists with conducting training risk/needs assessment and developing training strategy and programs.
  • Responsible for communicating business related issues or opportunities to next management level.
  • Collect and analyze data, and report metrics as established in processes and procedures 

Qualifications
Qualifications
  • Bachelor’s degree, or equivalent is required
  • Minimum 2 years of experience in the medical device industry is required
  • Proven quality system knowledge including 21 CFR Part 820 (QSR) & ISO 13485 is required
  • Medical Device Quality System experience is required
  • Experience with Document Management tools such as Agile and LMS tools such as Compliance Wire is preferred
  • Hands-on knowledge of computer applications including use of the Internet, Word, Excel, Power Point, Microsoft Share Point, Compliance Wire, SAP Agile and Outlook is preferred
  • Strong written and oral communication skills
  • Experience of office procedures, including filing, record management and archiving documentation is preferred
  • High attention to detail and ability to solve problems and communicate issues; ability to work on multiple projects simultaneously
  • Ability to work autonomously or in a team environment
 

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

 


Primary Location
United States-California-Milpitas-
Organization
AMO Manufacturing USA, LLC (6240)
Job Function
Quality Systems
Requisition ID
0110191119