Jabil is looking for a Quality Engineer III to ensure the site's Quality Management System (QMS) aligns with regulatory standards and supports medical manufacturing excellence, driving continuous improvement and supporting FinPack business opportunities.
Requirements
- In-depth knowledge of ISO 13485:2016, FDA 21 CFR Part 820, and 21 CFR Part 211.
- Familiarity with 21 CFR Part 4 for combination products.
- Strong understanding of CAPA processes and root cause investigations.
- Experience conducting audits and implementing corrective actions.
- Exceptional attention to detail in documentation, reporting, and compliance activities.
- Strong communication skills, both verbal and written, with the ability to train and collaborate across departments.
- Proficiency in Microsoft Office and quality management software systems.
Responsibilities
- Evaluate and align the site’s QMS with ISO 13485:2016, FDA 21 CFR Part 820, and 21 CFR Part 211.
- Develop and execute strategic plans to support FinPack business opportunities and regulatory compliance.
- Lead harmonization of site-specific procedures with corporate global policies.
- Conduct internal audits to identify deficiencies and implement corrective actions.
- Maintain and periodically review QMS documentation to ensure accuracy and compliance.
- Lead and support lean and continuous improvement initiatives related to the QMS.
- Deliver QMS and GMP training, including updates to industry standards and regulatory requirements.
Other
- Minimum of 7 years of experience in quality systems or regulatory compliance.
- Experience in medical manufacturing and quality control is essential.
- Or an equivalent combination of education and experience.
- Ability to organize and present complex information clearly and professionally.
- Bachelor’s degree preferred.
