At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.
SUMMARY
This position will support the sustaining of the Quality System for the Plant. Responsible for the development, recovery and maintenance of the documentation related to the CAPA and Complaint Management System and Regulatory Compliance. Responsible for the Management of the CAPA and Complaints.
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ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Guarantee full compliance of all the CAPA and Complaint investigations.
- Follow up of open CAPA's , Complaints and NCMRs.
- Serve as a coach to the Investigator during the investigation process.
- CAPA SME
- Coordination and Measurement of the activities related to the maintenance of the Quality Management System, including Customer Complaints and CAPA's.
- Maintain CAPA and Complaints metrics for the Plant.
- Assists in the preparation for External Audits.
- Manage the Document Creation in the applicable system related to the process under responsibility.
- Assists in the process for ensuring that corrective actions (CAPA) are completed in accordance with relevant ISO requirements (ISO 13485), CFR Part 820, Problem Solving methods, and that documentation is complete and compliant with requirements.
- Support the internal supplier third party and FDA quality audits.
- Support all company safety and quality programs and initiatives.
- May perform other duties and responsibilities as assigned.
- Support all company safety and quality programs and initiatives.
- May perform other duties and responsibilities as assigned.
- Provide support to all Safety, Health and Environment (EHS) programs and initiatives in order to support our zero accident culture.
MINIMUM REQUIREMENTS
- Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required.
- Good knowledge of CAPA and Complaint Investigations
- Bilingual English speaking and writing
- BS degree or equivalent
- 4+ years of experience in CAPA and complaint investigations.
- Good knowledge in ISO 13485 and CFR Part 820
- Or an equivalent combination of education, training or experience.
Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, age, disability, genetic information, veteran status, or any other characteristic protected by law.
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 your local police department. Any scam job listings should be reported to whatever website it was posted in.
Accommodation Statement
If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.