Quality Assurance Engineer

ZOLL Medical•Chelmsford, MA

3d•Hybrid

About The Position

The Product Quality Assurance Engineer supports product quality throughout the product lifecycle, focusing on complaint investigations, risk management support, and product quality monitoring. The role partners with Engineering, Manufacturing, Regulatory, and Post-Market teams to investigate and analyze product performance and help improve medical-device reliability, patient safety, and regulatory compliance. The position contributes to investigations, risk management files, complaint and field-performance analysis, CAPA and nonconformance activities, design reviews, and design verification and validation quality processes. It maintains accurate quality records and supports continuous improvement. The role is described as hybrid/remote, with occasional travel as needed for team meetings, training, investigations, audits, or site support. ZOLL does not provide immigration-related sponsorship for this role.

Requirements

Bachelor's degree in Engineering or a related technical discipline.
At least 2 years of experience in quality engineering, product quality, or product engineering; preferably in a regulated industry.
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.
Ability to collaborate in a cross-functional team environment.
Strong written and verbal communication skills, including the ability to document findings and communicate with technical stakeholders.
Ability to work effectively in a remote environment while collaborating across teams and time zones.
Advanced English proficiency.

Nice To Haves

Internship, co-op, or early-career experience in medical devices, manufacturing, or a regulated industry.
Experience using quality system tools or data analysis tools.
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.

Responsibilities

Assist with product and complaint investigations, including data gathering, product failure analysis, and root-cause analysis support.
Support product risk management, 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 resolve product quality issues.
Support design verification and validation quality activities through documentation review and participation in related quality processes.
Ensure product quality activities comply with applicable regulatory requirements, quality system standards, and internal procedures.
Maintain clear, accurate, and timely documentation of investigations, analyses, and quality records.
Contribute to continuous improvement initiatives related to product quality, field performance, and quality system effectiveness.