Contract position: A Post Market Surveillance Consultant is needed for a leader in electronics, healthcare, and lighting in the Rancho Cordova, CA area. This position will handle the receipt, processing, monitoring, and reporting of product defect complaints, Make MDR determination, and document all activities creating the summaries of the investigation. No per diem available. No travel required. Responsibilities for the Specialist
Requirements for the Specialist
- Work with Customer Service and customers/patients to gather additional information required for complaint initiation/investigations, including the retrieval of product samples and or durable equipment retrieval for evaluation.
- Apply knowledge of device regulatory requirements in order to support the Post Market Clinical Surveillance reporting process and evaluates complaints for reporting.
- CAPA support in response to audit readiness findings and in preparation for audits. Coordinate initiative to close out overdue Field Change Orders with global markets.
- Bachelor's degree and at least 15 years of professional experience in a relevant role.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.