Principal Quality Engineer, Medical Devices & CAPA Leader

NIPRO Corporation - Global; Lewisberry (PA); On-site; USD 120,000 - 180,000; Full time

Job summary

Nipro Medical Corporation is seeking a Principal Quality Engineer to lead quality systems, CAPA, and regulatory compliance at our Lewisberry, PA site. You will partner with Operations, Regulatory Affairs, and Product Development to drive quality excellence and patient safety.

The role focuses on CAPA leadership, audits, and continuous improvement using Lean Six Sigma methodologies, impacting product quality and site performance.

Qualifications

• Bachelor's degree in a scientific, engineering, or related technical discipline.
• 8–10+ years of Quality Systems experience within the medical device industry.
• Experience supporting medical device manufacturing operations in a regulated environment.
• Strong knowledge of FDA QSR, ISO 13485, and quality management systems.
• Proven success leading CAPA investigations, validations, and continuous improvement initiatives.

Responsibilities

• Lead and facilitate the site CAPA Review Board.
• Drive quality system compliance and support FDA, ISO 13485, and MDSAP requirements.
• Ensure inspection readiness and support regulatory, customer, and internal audits.
• Lead and support CAPA investigations, root cause analysis, and corrective actions.
• Analyze quality and production metrics to identify trends and implement improvements.
• Drive continuous improvement initiatives utilizing Lean and Six Sigma methodologies.
• Review and approve quality records, validation documentation, engineering changes, and quality plans.
• Mentor Quality Engineers and provide regulatory guidance to cross-functional teams.

Skills

Quality Systems

CAPA

Regulatory Compliance

Lean Six Sigma

Risk Management

Education

Bachelor's degree in a scientific or engineering field

Tools

FMEA

NCMR

Control Plans

Process Capability

Audit Management

Job description

Nipro Medical Corporation is seeking a Principal Quality Engineer to lead quality systems, CAPA, and regulatory compliance at our Lewisberry, PA site. You will partner with Operations, Regulatory Affairs, and Product Development to drive quality excellence and patient safety.

The role focuses on CAPA leadership, audits, and continuous improvement using Lean Six Sigma methodologies, impacting product quality and site performance.