Job Description:

　　Pay: $27+/hr

　　Shift: 8am – 4:30pm

　　Location: San Mateo

　　6 month contract to hire

　　Duties Overview:

　　• Lead and oversee the management of the product complaint system and processes

　　• Evaluate and document product complaints, ensuring comprehensive responses.

　　• Collaborate with cross-functional departments (Regulatory, Clinical, R&D, etc.) to gather essential information for the resolution of complaint investigations

　　• Provide coordination and documentation support for complaints requiring Medical Device Reporting (MDR)

　　• Conduct thorough device investigations, including reviewing device history records, inspections, and testing as necessary to complete investigations

　　• Collaborate closely with the Customer Care team to review and log complaints from SalesForce CRM

　　• Analyze complaint data and trends, reporting findings and identifying potential corrective or preventative actions

　　• Drive continuous improvement by offering constructive feedback on existing processes

　　• Adhere strictly to Good Documentation Practices and Good Manufacturing Processes

　　• Ensure compliance with all corporate, regulatory, safety, and production policies and procedures

　　• Maintain an exemplary attendance record

　　• Exhibit strong organizational skills and an attention to detail

　　• Work independently as necessary to support quality objectives

　　• Fulfill any other duties as assigned

　　Skills & Qualifications:

　　• Minimum AA degree in a related field or equivalent level of experience

　　• 3+ years of medical device complaint handling process

　　• Familiarity with CRM & Complaint handling system such as SalesForce, Arena, or equivalent

　　• Familiarity and understanding in a regulated environment (ISO 13485 & FDA)

　　• Working knowledge using common inspection tools, including operation of automated visual inspection systems.

　　• Working statistical knowledge for trend analysis

　　• Experience working with MS Office and Excel or Google Docs and Sheets

　　• Excellent technical verbal/written communication skills

　　• Process orientation when planning and performing work

　　If interested, please call 408 346 9343 .

　　About Aerotek:

　　We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

　　The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.