SUMMARY
The Quality Analyst provides guidance, interpretation, and direction to stakeholders on all matters pertaining to compliance with the established document control procedures. This includes the controlled electronic document management system, change control system, and record retention activities.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Administration of the document control process as the site SME.
Site leader for administration of the change control process.
Acts as the Change Control Administrator for review, routing, and implementation of changes.
Reports weekly to management of change control statuses.
Site leader for administration of deviations for review and approval.
Interfaces with customer regarding deviations via their electronic document control system.
Administration of training for the site.
Document control system administration.
Create and maintain quality training matrix.
Conduct training for quality related subjects, i.e., GDP, Document Control, Change Control, etc.
Administration of the Quality Record retention process, including logging, filing, and sending off-site to approved vendor.
Develops, reviews, and implements new procedures, work instructions, and other documents as needed.
Overseas control of documentation per ISO 13485 and 21 CFR part 820. Support internal, corporate, notified body, FDA, and other audits.
May perform other duties and responsibilities as assigned.
MINIMUM REQUIREMENTS
Bachelor’s degree / 3 years experience in manufacturing in a quality or manufacturing engineering emviornment. Master degree Mathematics/Statistics and Six Sigma Black Belt certification preferred.
BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact the Federal Bureau of Investigations internet crime hotline (www.ic3.gov), the Federal Trade Commission identity theft hotline (www.identitytheft.gov) and/or your local police department. Any scam job listings should be reported to whatever website it was posted in.
Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law.
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