Quality Engineer - QMS

Jabil•Asheville, NC

12d•Onsite

About The Position

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. This role is full time on-site in Asheville, NC. How will you make an impact? 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.

Requirements

Bachelor’s degree preferred.
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.
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.

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.
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.