Sr. Product Complaint Analyst
We have a client in the San Diego area looking for a Sr. Product Compliant Analyst. They are looking for candidates in San Diego but open to remote candidates as well. 3+ years recent experience in Quality/Regulatory Affairs in a in vitro diagnostics device or medical device required. Also, complaint handling experience is highly desired.
location: SAN DIEGO, California
job type: Contract
work hours: 8am to 4pm
Primary QA point of contact for on-market medical device and diagnostic complaint assessments and post market surveillance
Performing QA Review of medical device complaints and ensure adequacy of complaint records (e.g. investigations, CAPA, NCs) Identifies, collects, trends, analyzes, and summarizes product quality data to identify product quality issues
Facilitate the evaluation of complaints, including assessment, investigation, containment, review, approval and determination of on-going needs
Work closely with investigation teams to identify, assess and track potential adverse events and/or field actions and escalate to Regulatory in a timely manner
Participate as the subject matter expert during audits and/or inspections as needed
Actively participate on Quality teams and cross-functional project teams as needed
Identifies product and process improvements to reduce complaints and cost of poor quality
Promotes global awareness and provides training to policy and procedures
Provides support in the execution of field actions
- Experience level: Experienced
- Minimum 4 years of experience
- Education: Bachelors
- Technical Analyst
- Product Design
- Medical Device
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.