Quality Assurance Specialist
Actalent • Bay Minette, Alabama, United States
Salary: USD 60,000–70,000 per year
Role & seniority: Senior QA/Regulatory Affairs support (assists QA/RA Manager); 5+ years quality experience in manufacturing; regulated medical devices background.
Stack/tools: Regulatory standards and frameworks (ISO13485, FDA regulations, MDSAP, MDD/MDR); QMS documentation and configuration management; internal audits; CAPA; Device History Records; Material Review Board; on-site work.
Top 3 responsibilities
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Help ensure regulatory compliance (FDA, Health Canada, ISO13485, MDSAP, MDD/MDR) and support external audits.
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Lead/perform internal QMS audits, maintain documentation, manage CAPAs, and train as needed.
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Verify product quality, investigate nonconformances, and participate in MRB decisions; audit equipment and processes.
Must-have skills
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5+ years QA experience in a manufacturing/re regulated setting.
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Strong knowledge of ISO13485, FDA regulations, and related international standards.
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Detail-oriented, highly organized with effective communication and collaboration.
Nice-to-haves
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Experience with external audits (FDA Notified Bodies, etc.), MDSAP processes.
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Familiarity with QMS tooling, CAPA systems, and equipment/process auditing.
Location & work type: Permanent, fully onsite in Bay Minette, AL. Application window through Nov 17, 2025.
Full Description
Description
ESSENTIAL DUTIES AND RESPONSIBILITIES
Regulatory
Assist QA/RA Manager to ensure regulatory requirements are met. Compliance includes FDA, Health Canada, ISO13485, MDSAP, MDD/MDR, etc. Support external audits by Regulatory Agencies (FDA, Notified Body, etc.)
Quality Management System
Internal Audits in accordance with ISO13485, MDSAP, MDD/MDR. Configuration Management of QMS Documentation. Create and Implement internal quality procedures and forms. Collect, assemble, and maintain Device History Records. Perform QMS Training as needed. Perform CAPAs for QMS nonconformances.
Product Quality
Verify accuracy and completeness of products. Research cause and corrective action of nonconformances. Act as a member of the Material Review Board. Auditing of equipment and processes.
Qualifications
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
Job Type & Location
This is a Permanent position based out of Bay Minette, AL.
Pay And Benefits
The pay range for this position is $60000.00 - $70000.00/yr.
Competitive Benefits Offered By The Company
Workplace Type
This is a fully onsite position in Bay Minette,AL.
Application Deadline
This position is anticipated to close on Nov 17, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
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, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
