STAAR Surgical · 6 days ago
Product Complaint Associate
Monrovia, CA
Full-time
Hybrid
Entry Level
$25/hr - $32/hr
1+ years expSTAAR Surgical is a company focused on ophthalmic products, and they are seeking a Product Complaint Associate to manage and investigate product complaints. The role involves coordinating with various departments to ensure compliance with regulations and maintaining accurate documentation of complaints and investigations.
BiotechnologyHealth CareManufacturingMedical Device
Responsibilities
Act as consolidation point for receiving, processing, investigating and reporting product complaints
Coordinate and/or perform the evaluation, investigation, follow-up and documentation of all STAAR product complaints. Maintain complaint files
Coordinate complaint investigations according to complaint handling procedures, which includes but is not limited to:
Interface with physicians and/or health care professionals regarding information relevant to the product complaint
Interface and coordinate with Regulatory, Quality, Clinical Affairs and Medical Affairs to conduct investigations, risk assessments and determine reporting requirements
Perform prompt handling of complaints, including identification and evaluation of device product complaints for potential reportable adverse event according to procedures
Inform management responsible for complaint handling when information in a complaint suggests that action may be required to prevent unreasonable risk of substantial harm to the public, that there is an indication of a trend or that there are unusual adverse events
Ensure incident reports (e.g. Medical Device Reports, Health Canada Reports, Vigilance reports, etc.) are submitted in compliance with respective regulations (e.g. U.S. FDA Regulations, Canadian Medical Device Regulations, MDD/MDR, MDSAP, etc.)
Ensure accuracy, integrity, completeness and consistent content of product complaint reports, investigations, incident reports, in the complaint files and electronic complaint database
Support external (e.g. FDA, DEKRA, etc.) and internal audits as required
Provide support, as required for other aspects of the post-market surveillance system (i.e., data analysis of complaint reports, files and adverse event reporting logs)
Provide support for medical affairs activities, as requested
Other duties as assigned
Qualification
Required
High School graduate or equivalent required
Demonstrated understanding of, and ability to interpret, regulations and guidelines governing medical device manufacturing, including but not limited to, CFRs, ISO 13485, MDD, CMDR, MDSAP, MDR
Proficiency in MS Word and Excel
Ability to work well within a team and interdepartmentally
Special competencies: timely and quality decision making; well-developed organizational ability, time management reasoning and problem-solving skills
Good communication skills, written and verbal
Preferred
Associate's Degree or higher desired
1 year's ophthalmic experience, or equivalent combination of education and experience, preferred
3 years' experience in FDA regulated industry preferred; experience handling complaints and medical device reporting is highly desirable
Company
STAAR Surgical
STAAR, which has been dedicated solely to ophthalmic surgery for over 40 years, designs, develops, manufactures and markets implantable lenses for the eye.
501-1000 employees
H1B Sponsorship
STAAR Surgical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (8)
2023 (6)
2022 (10)
2021 (2)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
unknown2025-08-05Acquired
1990-11-02IPO
Leadership Team
Keith Holliday
Chief Technology Officer
Recent News
2026-01-16
Business Wire
2026-01-07
Company data provided by crunchbase