[Hiring] Senior Product Quality Assurance Engineer @ZOLL Medical Corporation

Role Description

The Senior Product Quality Assurance Engineer provides technical leadership for product quality throughout the product lifecycle, with a strong focus on field performance, risk management, and continuous improvement. This role leads complex investigations, partners cross-functionally with Engineering, Manufacturing, Regulatory, and Post-Market teams, and drives actions that improve product reliability, patient safety, and compliance for medical devices.

Essential Functions

• 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.

Qualifications

• 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.

Requirements

• 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.

Preferred Languages

• English - Advanced

Travel Requirements

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

Physical Demands

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

Benefits

• The annual salary for this position is: $119,100.00 to $178,600.00.
• This position is eligible for an annual bonus in accordance with the company's bonus plan.
• Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com .