• Quality Assurance Specialist

    Actalent (Bay Minette, AL)


    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 [email protected] (%[email protected]) for other accommodation options.