Quality Assurance Specialist
Actalent • Bay Minette, Alabama, United States
Salary: USD 60,000–70,000 per year
Role & seniority: Intermediate QA/Regulatory role; supports QA/RA Manager in a regulated manufacturing environment.
Stack/tools: Quality Management System (QMS); ISO13485, MDSAP, FDA regulations familiarity; Document control; CAPA management; internal audits; Device History Records; audit facilitation.
Top 3 responsibilities
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Assist QA/RA Manager to ensure regulatory requirements are met and support external audits (FDA, Notified Body, etc.).
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Manage QMS activities: internal audits, documentation control, procedures/forms, training, and CAPAs for nonconformances.
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Product quality oversight: verify product accuracy, investigate nonconformances, act in Material Review Board, audit equipment/processes.
Must-have skills
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5+ years of quality experience in a manufacturing setting (regulated industry)
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Strong knowledge of ISO13485 and FDA regulations
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Experience with audits, QA/QC, document control, CAPA
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Excellent attention to detail and organizational skills
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Effective communication and collaboration abilities
Nice-to-haves
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Prior medical devices experience
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Familiarity with international standards beyond ISO13485 and FDA
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Experience with MDSAP, MDD/MDR
Location & work type: Permanent, onsite, Bay Minette, AL.
Full Description
Description
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.
Skills
Quality assurance, Quality control, Audit, Document control, Capa, Inspection, Fda, Quality assurance testing
Top Skills Details
Quality assurance,Quality control,Audit,Document control,Capa
Additional Skills & Qualifications
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 & 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 14, 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.
