Quality Specialist

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

• Bachelor's degree in a scientific or related field such as Chemistry, Biology, or Nursing.
• 2–3 years of experience in complaint handling, quality assurance, or regulatory affairs within the medical device or pharmaceutical industry.
• Strong understanding of FDA regulations, ISO standards, and global complaint handling requirements.
• Excellent written and verbal communication skills.
• High attention to detail and strong organizational skills.
• Proficiency in Microsoft Office and complaint management systems like TrackWise.
• Ability to work independently and manage multiple priorities in a fast-paced environment.

Job Type & Location

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

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: • 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)

This is a fully onsite position in Santa Clara,CA.

This position is anticipated to close on Dec 12, 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.

Salary : $48 - $50