Recall Specialist

Baystate Health•Holyoke, MA

21h•Hybrid

About The Position

The Recall Specialist plays a critical role in ensuring patient safety and regulatory compliance by managing product recalls across the hospital system. This position serves as the primary point of contact for all recall-related communications, coordinating with clinical departments, vendors, and regulatory agencies to ensure timely identification, removal, and documentation of recalled products. The role also supports the investigation and coordination of device failures, ensuring appropriate escalation, documentation, and follow‑up with manufacturers and internal stakeholders.

Requirements

Experience in a hospital or healthcare setting.
Knowledge of Joint Commission and CMS standards related to product recalls and device-failure reporting.
Highschool diploma or GED
Strong organizational skills and attention to detail
Excellent communication and interpersonal skills
Proficiency in Microsoft Office Suite and supply chain management systems (e.g., Lawson, PeopleSoft, SAP).
Ability to analyze and document device‑failure trends and escalate appropriately
5+ years of experience in healthcare supply chain, inventory management, or regulatory compliance
Familiarity with FDA recall classifications, device‑failure reporting pathways and healthcare product categories
Ability to work independently and manage multiple priorities in a fast-paced environment
GED or HiSET (Required)

Nice To Haves

Certification in healthcare supply chain or regulatory affairs (e.g., CMRP, RAC) is a plus.

Responsibilities

Monitor and respond to product recall notifications from manufacturers, distributors, and regulatory agencies (e.g., FDA, USDA).
Coordinate with clinical and non-clinical departments to identify and remove affected products from inventory and patient care areas.
Manage and document device‑failure reports, including coordinating with Biomedical Engineering, Risk Management, and vendors to ensure proper evaluation and follow‑up.
Maintain accurate records of recall actions, including documentation of product disposition and communication logs.
Collaborate with Supply Chain, Pharmacy, Biomedical Engineering, and other departments to ensure comprehensive recall coverage.
Communicate recall and device-failure information clearly and promptly to stakeholders, including leadership and frontline staff.
Ensure compliance with hospital policies and regulatory requirements related to product recalls.
Support audits and inspections by providing recall documentation, device‑failure documentation and process overviews.
Develop and maintain recall tracking systems and dashboards for reporting and analysis.
Participate in continuous improvement initiatives to enhance recall response efficiency and effectiveness.

Benefits

Excellent Compensation
High-quality, low-cost medical, dental and vision insurance
Generous PTO with scheduled earned increases
Continuing education support and reimbursement
First Time Home Buyers Financial Packages
Farm Share Memberships
403b retirement company match & annual company contribution increase based on years of service
Free money coach advice from a certified professional
Wellbeing programs that include but are not limited to mental, physical, and financial health
Pet, home, auto and personal insurance
Life insurance
Reimbursement for a variety of wellbeing activities, included but limited to gym membership and equipment, personal trainer, massage and so much more!
Wellbeing programs that include but are not limited to mental, physical, and financial health