Hiring: Product Quality Assurance Engineer Company: ZOLL Medical Corporation Location: Chelmsford, MA Job Posted Time: 2026-09-03 14:43:48 Employment Type: Internship / Remote Target Skills & Keywords : Quality Assurance, R, Risk Management, Root Cause Analysis About the job Experience: •2+ years of experience in quality engineering, product quality, or product engineering, preferably in a regulated industry. •Internship, co-op, or early career experience in medical devices, manufacturing, or a regulated industry. Required Skills: •Assist with product and complaint investigations, including data gathering, product failure analysis, and support for root cause analysis activities. •Support product risk management activities, including documentation updates, risk assessments, and maintenance of risk management files in accordance with applicable standards and procedures. •Analyze complaint, service, and field performance data to identify trends, recurring issues, and opportunities for product quality improvement. •Support CAPA and nonconformance activities related to product quality issues, including documentation, tracking, and follow-up actions. •Participate in product design reviews and quality assessments to help ensure quality requirements are addressed throughout the product lifecycle. •Partner with Design Assurance, R&D, Manufacturing, Supplier Quality, Regulatory Affairs, and Clinical/Post-Market teams to support resolution of product quality issues. •Support design verification and validation quality activities through review of documentation and participation in related quality processes. •Ensure product quality activities are performed in compliance with applicable regulatory requirements, quality system standards, and internal procedures. Qualifications: •Basic understanding of engineering principles, data analysis, and problem-solving techniques. •Strong organizational skills and attention to detail, with the ability to manage documentation and follow established processes. •Demonstrated capacity to work collaboratively in a cross-functional team environment. •Strong written and verbal communication skills, with the ability to clearly document findings and communicate with technical stakeholders. •Demonstrated capacity to work effectively in a remote environment while collaborating across teams and time zones. •Operational familiarity with complaint handling, CAPA, nonconformance systems, or risk management processes. •Exposure to medical device design controls, verification and validation, or post-market quality activities. •Knowledge of FDA Quality System requirements, ISO 13485, or ISO 14971 is a plus •Hybrid/Remote role with occasional travel as needed for team meetings, training, investigations, audits, or site support •Bachelor's Degree in Engineering or a related technical discipline. Compensation: •Flexible work environment (work from home / hybrid options) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!