Quality Complaint Specialist

Job Title: Quality Complaint SpecialistJob Description We are seeking a detail-oriented Quality Complaint Specialist to join our team. This role involves handling investigations into complaints, including conducting root cause analyses and coordinating with cross-functional teams such as R&D, Manufacturing, and Regulatory. The position requires determining regulatory reportability and submitting Medical Device Reports (MDRs) to the appropriate agencies. You will also be responsible for maintaining complaint records in compliance with internal procedures and regulatory standards. Responsibilities + Conduct investigations into complaints, including root cause analysis and coordination with cross-functional teams. + Determine regulatory reportability and submit Medical Device Reports (MDRs) to 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 are properly utilized. + Assist in the development of complaint closure letters and customer communications. Essential Skills + 2u20133 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 (e.g., TrackWise). Additional Skills & Qualifications + Bacheloru2019s degree in a scientific or related field (e.g., Chemistry, Biology, Nursing). + Ability to work independently and manage multiple priorities in a fast-paced environment. Work Environment The work environment fosters a good company culture and supports continuous learning and development. The role requires collaboration with various departments and offers exposure to different aspects of quality assurance and regulatory affairs. Work involves utilizing advanced complaint management systems and adhering to industry standards to ensure compliance. 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: u2022 Medical, dental & vision u2022 Critical Illness, Accident, and Hospital u2022 401(k) Retirement Plan u2013 Pre-tax and Roth post-tax contributions available u2022 Life Insurance (Voluntary Life & AD&D for the employee and dependents) u2022 Short and long-term disability u2022 Health Spending Account (HSA) u2022 Transportation benefits u2022 Employee Assistance Program u2022 Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Santa Clara,CA. Application Deadline This position is anticipated to close on Nov 21, 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 ( ) for other accommodation options.

Created: 2025-11-12