ZOLL Medical

Product Quality Assurance Engineer

Chelmsford, MA · Internship

No sponsorship$82k-$90kDetected 2 days ago

Data AnalysisProduct ManagementFDA RegulatoryMedical DevicesCommunicationProblem SolvingOrganizational SkillsRegulatory Affairs

About the role

Internship, co-op, or early career experience in medical devices, manufacturing, or a regulated industry.

The Product Quality Assurance Engineer supports product quality throughout the product lifecycle, with a focus on complaint investigations, risk management support, and product quality monitoring.
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.
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.
Maintain clear, accurate, and timely documentation of investigations, analyses, and quality records.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Ability to work collaboratively in a cross-functional team environment.
Familiarity with complaint handling, CAPA, nonconformance systems, or risk management processes.

Analyze complaint, service, and field performance data to identify trends, recurring issues, and opportunities for product quality improvement.
Ensure product quality activities are performed in compliance with applicable regulatory requirements, quality system standards, and internal procedures.
Contribute to continuous improvement initiatives related to product quality, field performance, and quality system effectiveness.
Bachelor's Degree in Engineering or a related technical discipline.
2+ years of experience in quality engineering, product quality, or product engineering, preferably in a regulated industry.
Experience using quality system tools or data analysis tools is a plus.

$82,400.00 to $90,000.00
Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate.
For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee's primary work location.

Exposure to medical device design controls, verification and validation, or post-market quality activities.
Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.
ZOLL Medical does not provide immigration-related sponsorship for this role.

ZOLL is a fast-growing company that operates in more than 140 countries around the world.
Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran.

This listing is sourced directly from ZOLL Medical's careers page and normalized into a canonical job model.