Actalent
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Quality Assurance Specialist
role at
Actalent .
Essential Duties and Responsibilities
Regulatory o Assist QA/RA Manager to ensure regulatory requirements are met. o Compliance includes FDA, Health Canada, ISO13485, MDSAP, MDD/MDR, etc. o Support external audits by Regulatory Agencies (FDA, Notified Body, etc.)
Quality Management System o Internal Audits in accordance with ISO13485, MDSAP, MDD/MDR. o Configuration Management of QMS Documentation. o Create and Implement internal quality procedures and forms. o Collect, assemble, and maintain Device History Records. o Perform QMS Training as needed. o Perform CAPAs for QMS nonconformances.
Product Quality o Verify accuracy and completeness of products. o Research cause and corrective action of nonconformances. o Act as a member of the Material Review Board. o Auditing of equipment and processes. o Miscellaneous duties as assigned.
Additional Skills & Qualifications
Experience in quality assurance within a regulated industry (medical devices preferred).
Familiarity with ISO13485, FDA regulations, and international standards.
Strong attention to detail and organizational skills.
Effective communication and collaboration abilities.
5+ years of quality experience in a manufacturing setting.
Experience Level: Intermediate Level.
Job Type: Permanent. Location: Bay Minette, AL.
Pay range: $60,000 - $70,000 per year.
Application Deadline: Nov 14, 2025.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, please email actalentaccommodation@actalentservices.com for other accommodation options.
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Quality Assurance Specialist
role at
Actalent .
Essential Duties and Responsibilities
Regulatory o Assist QA/RA Manager to ensure regulatory requirements are met. o Compliance includes FDA, Health Canada, ISO13485, MDSAP, MDD/MDR, etc. o Support external audits by Regulatory Agencies (FDA, Notified Body, etc.)
Quality Management System o Internal Audits in accordance with ISO13485, MDSAP, MDD/MDR. o Configuration Management of QMS Documentation. o Create and Implement internal quality procedures and forms. o Collect, assemble, and maintain Device History Records. o Perform QMS Training as needed. o Perform CAPAs for QMS nonconformances.
Product Quality o Verify accuracy and completeness of products. o Research cause and corrective action of nonconformances. o Act as a member of the Material Review Board. o Auditing of equipment and processes. o Miscellaneous duties as assigned.
Additional Skills & Qualifications
Experience in quality assurance within a regulated industry (medical devices preferred).
Familiarity with ISO13485, FDA regulations, and international standards.
Strong attention to detail and organizational skills.
Effective communication and collaboration abilities.
5+ years of quality experience in a manufacturing setting.
Experience Level: Intermediate Level.
Job Type: Permanent. Location: Bay Minette, AL.
Pay range: $60,000 - $70,000 per year.
Application Deadline: Nov 14, 2025.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, please email actalentaccommodation@actalentservices.com for other accommodation options.
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