Jabil
Quality Engineer III - Quality Managment Systems
Jabil, Royal Pines, North Carolina, United States
Overview
Quality Engineer III - Quality Management Systems As a
Quality Engineer III , you will play a critical role in ensuring that the site’s Quality Management System (QMS) aligns with regulatory standards and supports medical manufacturing excellence. You will lead initiatives to maintain compliance with ISO 13485:2016, FDA 21 CFR Part 820, and 21 CFR Part 211, while driving continuous improvement and supporting FinPack business opportunities. Your work will directly impact product quality, regulatory readiness, and operational efficiency—requiring exceptional attention to detail, strong communication skills, and a deep understanding of medical manufacturing quality control.
What will you do?
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.
Provide introductory training during employee orientation and ongoing education across departments.
Collaborate cross-functionally to uphold high standards in documentation and reporting.
Support the Behavioral Based Quality (BBQ) program.
Ensure ongoing GMP compliance in all practices, documentation, and processes.
Organize verbal and written communication clearly and professionally.
Maintain compliance with safety, security, and regulatory policies.
Perform other duties as assigned.
How will you get here? Education
Bachelor’s degree preferred.
Experience
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.
Knowledge, Skills, Abilities
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.
Ability to organize and present complex information clearly and professionally.
Proficiency in Microsoft Office and quality management software systems.
Note: This description reflects the responsibilities and qualifications for the Quality Engineer III - Quality Management Systems role. Any references to unrelated postings, sign-in prompts, or other roles have been removed to focus on the position specifics.
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Quality Engineer III - Quality Management Systems As a
Quality Engineer III , you will play a critical role in ensuring that the site’s Quality Management System (QMS) aligns with regulatory standards and supports medical manufacturing excellence. You will lead initiatives to maintain compliance with ISO 13485:2016, FDA 21 CFR Part 820, and 21 CFR Part 211, while driving continuous improvement and supporting FinPack business opportunities. Your work will directly impact product quality, regulatory readiness, and operational efficiency—requiring exceptional attention to detail, strong communication skills, and a deep understanding of medical manufacturing quality control.
What will you do?
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.
Provide introductory training during employee orientation and ongoing education across departments.
Collaborate cross-functionally to uphold high standards in documentation and reporting.
Support the Behavioral Based Quality (BBQ) program.
Ensure ongoing GMP compliance in all practices, documentation, and processes.
Organize verbal and written communication clearly and professionally.
Maintain compliance with safety, security, and regulatory policies.
Perform other duties as assigned.
How will you get here? Education
Bachelor’s degree preferred.
Experience
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.
Knowledge, Skills, Abilities
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.
Ability to organize and present complex information clearly and professionally.
Proficiency in Microsoft Office and quality management software systems.
Note: This description reflects the responsibilities and qualifications for the Quality Engineer III - Quality Management Systems role. Any references to unrelated postings, sign-in prompts, or other roles have been removed to focus on the position specifics.
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