Job TypeHybridJob SummaryThe Product Quality Assurance Engineer supports product quality throughout the product lifecycle, with a focus on complaint investigations, risk management support, and product quality monitoring. This role partners with Engineering, Manufacturing, Regulatory, and Post-Market teams to support investigations, analyze product performance, and contribute to activities that improve product reliability, patient safety, and compliance for medical devices.
Essential Functions- 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.
- 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.
Required/Preferred Education and Experience- 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
- Internship, co-op, or early career experience in medical devices, manufacturing, or a regulated industry
- Experience using quality system tools or data analysis tools is a plus
Knowledge, Skills and Abilities- 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 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.
- Ability to work effectively in a remote environment while collaborating across teams and time zones.
- 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
Preferred LanguagesTravel Requirements- Hybrid/Remote role with occasional travel as needed for team meetings, training, investigations, audits, or site support
Physical DemandsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Standing - Occasionally
- Walking - Occasionally
- Sitting - Constantly
- Talking - Occasionally
- Hearing - Occasionally
- Repetitive Motions - Frequently
The annual salary for this position is:
$85,000.00 to $100,000.00
This position is eligible for an annual bonus in accordance with the company's bonus plan. Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.
Applications will be accepted on an ongoing basis until this position is filled. 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.
