Quality Complaint Specialist

Job Description

Job Description

Job Title : Quality Complaint Specialist

Job Description

We are seeking a dedicated Quality Complaint Specialist to join our team. The role involves managing and investigating quality complaints, ensuring compliance with regulatory standards, and supporting continuous improvement initiatives. This position requires a strong understanding of complaint handling processes within the medical device or pharmaceutical industry.

Responsibilities

• Conduct investigations into complaints, including root cause analysis and coordination with cross-functional teams such as R&D, Manufacturing, and Regulatory.
• Determine regulatory reportability and submit Medical Device Reports (MDRs) to the appropriate agencies.
• Maintain complaint records in accordance with internal procedures and regulatory standards.
• Generate trend reports and metrics to identify recurring issues and support continuous improvement.
• Participate in CAPA (Corrective and Preventive Action) activities related to complaint findings.
• Support audit and inspection readiness by ensuring complaint files are complete and compliant.
• Collaborate with IT and other departments to ensure complaint handling systems, such as TrackWise, are properly utilized.
• Assist in the development of complaint closure letters and customer communications.

Essential Skills

Job Type & Location

This is a Contract to Hire position based out of Santa Clara, CA.

Pay and Benefits

The pay range for this position is $48.00 - $50.00 / 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 Santa Clara,CA.

Application Deadline

This position is anticipated to close on Nov 30, 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.