Product Surveillance Associate I

CooperCompanies•North Tonawanda, NY

22h•Onsite

About The Position

The Product Surveillance Associate I supports post market surveillance activities for combination drug‑device products in compliance with applicable U.S. and international regulatory requirements, including 21 CFR Parts 210, 211, 820, and ISO 13485. This role focuses on the execution, documentation, and support of product complaint investigations and post market surveillance activities to help ensure product safety, performance, quality, and regulatory compliance throughout the product lifecycle, and works cross‑functionally with team members, Product Surveillance Engineers, and Quality leadership to identify potential risks, support appropriate escalation and remediation activities, and maintain accurate, inspection‑ready records that support the organization’s Quality Management System and regulatory obligations.

Requirements

Working knowledge of FDA Quality System and pharmaceutical regulations, including 21 CFR Parts 211 and 820, as they relate to complaint handling and post market surveillance.
Demonstrated ability to follow defined procedures and perform well‑documented, compliant investigations.
Basic understanding of risk assessment principles and escalation pathways (e.g., CAPA, HHE, trending), with ability to recognize when to seek guidance.
Strong written and verbal communication skills to clearly document findings and communicate investigation status to cross‑functional partners.
Good analytical and organizational skills, with the ability to manage multiple investigations and meet assigned timelines.
High attention to detail and strong data management skills, with commitment to accurate recordkeeping and compliance.
Ability to work effectively within cross‑functional teams and follow direction from senior team members.
2+ years of experience working in manufacturing environment preferably within a pharmaceutical and/or medical devices related field
1+ years of experience supporting product complaint investigations, post market surveillance, or quality activities within a regulated pharmaceutical, medical device, or combination product environment.

Nice To Haves

Experience supporting internal/external audits related to complaint handling or post market surveillance is a plus.

Responsibilities

Executes and supports product complaint investigations in accordance with approved procedures and under guidance from Product Surveillance Engineers or Quality leadership.
Performs and documents thorough, timely, and compliant investigations, including data collection, product history review, and preliminary assessments of product performance and potential patient impact.
Supports risk assessments by gathering data, documenting risk considerations, and assisting with evaluation of investigation outcomes to support escalation decisions (e.g., CAPA, HHE, trending, regulatory reporting).
Assists with root cause analysis activities by applying basic structured investigation tools and supporting cross‑functional discussions.
Supports follow‑up activities related to corrective and preventive actions, including documentation, milestone tracking, and effectiveness check support as assigned.
Maintains complete, accurate, and traceable complaint and post market surveillance records within designated systems; monitors assigned investigation timelines and communicates status updates.
Ensures documentation is clear, objective, contemporaneous, and compliant with internal procedures and regulatory requirements to support inspection readiness.
Provides support during internal and external audits and inspections, including documentation retrieval and responses related to complaint handling and post market surveillance.
Participates in continuous improvement initiatives related to post market surveillance and QMS processes through feedback, data review, and procedural adherence.
Escalates issues, delays, or potential risks to senior team members or management as appropriate.
Perform other duties as assigned.