Qa serp_jobs.h1.location_city

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

Additional Skills & Qualifications

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 :

Workplace Type

This is a fully onsite position in Vista,CA.

Application Deadline

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