Quality Engineer III – Quality Management Systems
Jabil
full-time
Posted on:
Location Type: Office
Location: Asheville • North Carolina • 🇺🇸 United States
Visit company websiteJob Level
SeniorLead
About the role
- 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.
Requirements
- Minimum of 7 years of experience in quality systems or regulatory compliance
- Experience in medical manufacturing and quality control is essential
- 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
- Ability to organize and present complex information clearly and professionally
- Proficiency in Microsoft Office and quality management software systems.
Benefits
- Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options
- 401K match
- Employee Stock Purchase Plan
- Paid Time Off
- Tuition Reimbursement
- Life, AD&D, and Disability Insurance
- Commuter Benefits
- Employee Assistance Program
- Pet Insurance
- Adoption Assistance
- Annual Base Pay Increase
- Community Volunteer Opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
ISO 13485:2016FDA 21 CFR Part 820FDA 21 CFR Part 211CAPA processesroot cause investigationsquality controlinternal auditscorrective actionsQMS documentationGMP compliance
Soft skills
attention to detailstrong communication skillsorganizational skillscross-functional collaborationprofessionalism