Philips Product Complaint Specialist 1 in Rancho Cordova, California
The Complaints Specialist (CS) performs investigations on Volcano returned product to address complaints and/or allegations of customer dissatisfaction. The CS will perform product analysis within the Failure Analysis Lab following good laboratory practices and Volcano established procedures. The CS utilizes a variety of test equipment, tools and devices in the execution of product analysis. CS notifies management and other required functions of investigation findings that are potential safety concerns.
The CS collaborates with Complaints Coordinators, Quality Engineers, Manufacturing Engineers and
R& D as needed to investigate complaint cases. This individual will support external and internal audit activities of the Volcano quality system as required.
Work with a variety of diverse persons within the company such as Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers, and Manufacturing personnel to facilitate the complaint handling process globally
Evaluate customer feedback, service records, and other sources of customer and internal for possible complaint.
Initiate complaint in process and applicable tool.
Evaluate incoming data and determine if it is sufficient to understand the nature of the complaint
Communicate with customers, call center reps and FSEs to gather more data on complaints as needed
Confirm complaint condition and determine corrective action (including CAPA as needed)
Communicate with complainant as needed to follow up on and resolve complaint; follow up with end user/customer via complaint submitter when needed
Assess if the Risk assessment is covering the hazard in the complaint
Complete all needed records in a timely and accurate manner
We are looking for
1+ years of experience in a medical device or regulated industry.
Basic understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
Local post market surveillance regulation (21CFR, MDD93/42/EEC, other applicable market regulations), ISO14971 Risk Management
Previous experience in Medical device and or applicable Consumer product
Product Knowledge is preferred
Experience in maintenance and or troubleshooting of technical systems
This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that’s not all. Quality is right on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role’s mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.