Post Market Specialist/ Complaints Associate Atlantic Group - 3.6 Billerica, MA Job Details Full-time | Contract $30 - $32 an hour 1 day ago Qualifications Bachelor's degree Attention to detail Quality improvement Internal audits FDA regulations Full Job Description Position Summary The Post Market Associate / Complaint Specialist is responsible for supporting post-market quality activities by managing product complaints, coordinating investigations, maintaining quality records, and ensuring compliance with applicable regulatory requirements. This role serves as a key liaison between customers and internal teams to facilitate timely complaint resolution while supporting continuous product quality and patient safety initiatives. Responsibilities Receive, review, document, and process product complaints in accordance with established procedures. Evaluate complaint information for completeness and obtain additional details from customers or internal stakeholders as needed. Initiate and coordinate complaint investigations with Quality, Engineering, Manufacturing, Regulatory Affairs, and Technical Support teams. Review investigation findings to determine root cause, product disposition, and required follow-up actions. Maintain accurate and complete complaint files within the electronic quality management system (eQMS). Ensure complaint records are processed within established timelines and meet regulatory requirements. Assist in determining reportability for adverse events and other regulatory reporting requirements. Support trending and analysis of complaint data to identify recurring product or process issues. Collaborate with cross-functional teams on corrective and preventive actions (CAPA) and product quality improvements. Prepare documentation and reports to support internal audits, external audits, and regulatory inspections. Assist with returned product evaluations and documentation of investigation findings. Maintain compliance with FDA Quality System Regulations, ISO 13485, and other applicable quality standards. Participate in continuous improvement initiatives related to complaint handling and post-market quality processes. Qualifications Bachelor's degree in Life Sciences, Biomedical Engineering, Quality, Healthcare, or a related scientific field preferred. 2+ years of experience in complaint handling, quality assurance, post-market activities, or medical device manufacturing. Experience working within a regulated medical device, biotechnology, pharmaceutical, or life sciences environment. Working knowledge of FDA regulations, ISO 13485, complaint handling requirements, and post-market quality processes. Experience using electronic quality management systems (eQMS) or complaint management software. Strong analytical, organizational, and problem-solving skills. Excellent written and verbal communication skills. Ability to prioritize multiple tasks while maintaining attention to detail. Proficiency with Microsoft Office applications. Preferred Qualifications Experience supporting Medical Device Reporting (MDR) or global vigilance reporting. Knowledge of CAPA, nonconformance investigations, and root cause analysis methodologies. Experience with quality systems such as TrackWise, MasterControl, Greenlight Guru, Veeva, or similar platforms. Familiarity with product complaint trending, data analysis, and regulatory documentation. Experience participating in FDA or ISO audits. #

INDBOS Pay:

$30.00 - $32.00 per hour

Work Location:

In person