Senior Product Quality Assurance Engineer

• Lead complex product and field failure investigations, including root cause analysis, data trending, and corrective action development.
• Drive product reliability and quality improvements across the product lifecycle, from development through post-market support.
• Lead and support risk management activities, including risk assessments, hazard analysis, and risk file updates in accordance with applicable standards and procedures.
• Partner with Design Assurance, R&D, Manufacturing, Supplier Quality, Regulatory Affairs, and Clinical/Post-Market teams to resolve quality issues and implement robust solutions.
• Support design verification and validation activities by providing quality oversight, reviewing protocols and reports, and ensuring compliance with internal and external requirements.
• Analyze complaint, service, and field performance data to identify trends, emerging risks, and opportunities for corrective and preventive action.
• Lead or support nonconformance, CAPA, and escalation activities related to product quality issues.
• Ensure product quality activities comply with applicable regulatory requirements, quality system standards, and internal procedures.
• Provide mentorship to engineers and team members, and help shape product quality strategies, best practices, and investigation approaches.
• Contribute to inspection readiness and support internal, customer, and regulatory audits as needed.

• Bachelor's Degree in Engineering or a related technical discipline
• 7-12 years of experience in product quality, quality assurance, or quality engineering, preferably in the medical device industry
• ASQ Certified Quality Engineer or similar certification is a plus

• Demonstrated experience leading complex investigations, root cause analysis, and product quality improvement initiatives.
• Strong knowledge of risk management principles and product lifecycle quality processes.
• Experience working in cross-functional environments to resolve technical and quality issues.
• Strong written and verbal communication skills, with the ability to present findings and recommendations clearly to technical and non-technical stakeholders.
• Ability to work independently in a remote environment while effectively collaborating across teams and time zones.
• Experience in medical device design controls, verification and validation, and post-market quality.
• Familiarity with CAPA, complaint handling, nonconformance systems, and field performance monitoring.
• Knowledge of FDA Quality System requirements, ISO 13485, and risk management standards such as ISO 14971.
• Experience mentoring junior engineers or leading technical quality efforts.

• English - Advanced

• Remote role with travel as needed for team meetings, investigations, audits, or site support

• Standing - Occasionally
• Walking - Occasionally
• Sitting - Constantly
• Talking - Occasionally
• Hearing - Occasionally
• Repetitive Motions - Frequently

The annual salary for this position is:

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.

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.

ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.