Quality Engineer III - Quality Managment Systems
Quality Engineer III - Quality Managment Systems
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Salary Not Disclosed
1 Vacancy
Job Description
How will you make an impact
As aQuality Engineer III you will play a critical role in ensuring that the sites 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 efficiencyrequiring exceptional attention to detail strong communication skills and a deep understanding of medical manufacturing quality control.
What will you do
- Evaluate and align the sites 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:
- Bachelors degree preferred.
Experience:
- Minimum of 7 years of experience in quality systems or regulatory compliance.
- Experience inmedical manufacturingandquality controlis 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.
- Exceptionalattention to detailin documentation reporting and compliance activities.
- Strongcommunication 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.
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
BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a 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 drivers license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft contact the Federal Bureau of Investigations internet crime hotline () the Federal Trade Commission identity theft hotline () and/or your local police department. Any scam job listings should be reported to whatever website it was posted in.
Jabil including its subsidiaries is an equal opportunity employer and considers qualified applicants for employment without regard to race color religion national origin sex sexual orientation gender identity age disability genetic information veteran status or any other characteristic protected by law.
Accessibility Accommodation
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 site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to or calling with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.#whereyoubelong
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Employment Type
Full-Time
