Senior Quality Assurance Engineer (Medical Devices)

Location: Pittsburgh, PA, United States

Annual salary: $96,000–$130,000.

Company

Develops medical devices, software, and related services for diagnosing and treating serious cardiopulmonary and respiratory conditions.

What you will do

• Lead CAPA management, internal audits, quality system effectiveness reviews, and compliance activities.
• Analyze quality data to identify potential problems and improvement opportunities.
• Develop and execute Lean, Six Sigma, Kaizen, and cost improvement initiatives.
• Lead risk analyses, including FMEAs and Fault Tree Analyses, for new and existing products.
• Manage non-product software validation projects and coordinate validation requirements.
• Support FDA premarket approval, nonconforming material, and Material Review Board processes.

Requirements

• Bachelor’s degree or equivalent experience in a technical or scientific discipline.
• At least five years of experience in an FDA-regulated medical device manufacturing environment.
• At least five years of experience in process development and validation for electromechanical assembly, testing, and service.
• Practical knowledge of process capability, process control, measurement system capability, and Gauge R&R.
• Experience with Lean methodologies is required.
• Ability to understand and apply medical device regulatory requirements, including FDA QSR, ISO 13485, MDD, and CMDR.

Nice to have

• Formal project management experience.
• Lean Six Sigma Black Belt certification.

Culture & Benefits

• Work focused on improving outcomes for cardiac and other cardiopulmonary patients.
• Benefits are provided through ZOLL’s comprehensive benefits plans.
• Reasonable accommodations are available for qualified individuals with disabilities.
• Applications are accepted until the position is filled.