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QA Specialist

QA Specialist

ActalentVista, California, USA
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Job Title : QA Specialist

Job Description

The QA Specialist is primarily responsible for overseeing the quality and regulatory aspects of the company. This includes the development and maintenance of the Quality Management System, obtaining FDA and ISO certifications, and product submission and registration.

Responsibilities

  • Plan and implement the organization's Quality Management System.
  • Participate in the Risk Management team, working with team members to identify and mitigate risks / issues.
  • Create necessary process and procedural documents within the Quality System.
  • Conduct internal audits to ensure compliance.
  • Receive, review, and respond to customer product complaints.
  • Facilitate audits from external regulatory bodies.
  • Create submission documentation for product registration.
  • Manage regulatory associates in the preparation, compilation, and submission of high-quality supplements, annual reports, control documents, etc. to FDA authorities.
  • File Vigilance Reports or Medical Device Reports to Competent Authority or FDA.
  • Review regulatory submissions and assign signature for approval.
  • Manage quality control over the entire submission lifecycle, including component tracking, workflow execution, and issue resolution.
  • Coordinate and facilitate submissions between departments.
  • Maintain full awareness of all regulatory activities on assigned projects and ensure project deadlines and performance standards are established and met.
  • Work to minimize regulatory issues and help prevent unnecessary regulatory delays.
  • Mentor and provide guidance to regulatory associates.
  • Evaluate changes to regulatory documents and formulate a strategy to ensure proper filing categories.
  • Evaluate complex regulatory issues and provide accurate and timely recommendations and alternatives.
  • Evaluate changes and sign-off on change control documents, ensuring correct filing category.
  • Represent Regulatory Affairs on interdepartmental project teams.
  • Interact with FDA and company sites via written and phone communication.
  • Perform other duties as assigned or as business needs require.

Essential Skills

  • ISO auditing
  • Quality Management System (QMS)
  • Quality assurance
  • Medical device auditing
  • CAPA (Corrective and Preventive Actions)
  • Audit management skills
  • Medical Device Reporting (MDR)

    • Additional Skills & Qualifications

  • Bachelor's degree from a four-year college or university or 5+ years of related experience and / or training or equivalent combination of education and experience.
  • Knowledge of Database Software (EPDM), Spreadsheet Software (Excel), Project Management Software, Word Processing Software (Word), Electronic Mail Software (Outlook), and Presentation software (PowerPoint).
  • Regulatory Affairs Certification Program preferred.
  • Excellent organizational, leadership, interpersonal communication, and computer skills.
  • Clear and conceptual thinking ability.
  • Excellent judgment and discretion; ability to handle multiple priorities simultaneously, meet deadlines, and manage work-related stress.
  • Friendly, courteous, service-oriented, professional, outgoing, and customer service-oriented.
  • Detail-oriented and able to work effectively under pressure while meeting deadlines.
  • Able to work independently and productively with minimum supervision.
  • Recognize problems, identify possible causes, and resolve routine problems.
  • Ability to establish and maintain a professional atmosphere for employees and clients.
  • Five years of QA / RA experience required.
  • Excellent understanding of FDA and ISO regulations.
  • Experience developing Quality Management Systems.
  • Experience working with external auditing agencies.
  • Experience with product registration including FDA 510k and European CE mark.

    • Work Environment

    The employee will be regularly required to sit, talk, or hear. Occasionally, the employee will need to stand, walk, use hands to feel or handle, and reach with hands and arms. Frequent contact with cleaning chemicals and cutting oils is expected. The noise level in the work environment is usually moderate. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

    Job Type & Location

    This is a Contract position based out of Vista, California.

    Pay and Benefits

    The pay range for this position is $48.00 - $48.00 / hr.

    Eligibility requirements apply to some benefits and may depend on your job

    classification and length of employment. Benefits are subject to change and may be

    subject to specific elections, plan, or program terms. If eligible, the benefits

    available for this temporary role may include the following :

  • Medical, dental & vision
  • Critical Illness, Accident, and Hospital
  • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
  • Life Insurance (Voluntary Life & AD&D for the employee and dependents)
  • Short and long-term disability
  • Health Spending Account (HSA)
  • Transportation benefits
  • Employee Assistance Program
  • Time Off / Leave (PTO, Vacation or Sick Leave)

    • Workplace Type

    This is a fully onsite position in Vista,CA.

    Application Deadline

    This position is anticipated to close on Sep 4, 2025.

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    Qa Specialist • Vista, California, USA