Principal Quality Engineer — Medical Devices Leader

EPM Scientific; Irvine (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

EPM Scientific is seeking a Principal Quality Engineer to provide strategic and hands-on leadership across product development, manufacturing, and quality systems. You will drive risk management, CAPA, and process validation while ensuring compliance with FDA regulations and ISO 13485.

You will mentor engineers, lead cross-functional teams, and oversee audits, inspections, and quality documentation to support post-market activities and supplier quality initiatives in a fast-paced environment.

Qualifications

• 10+ years of quality engineering experience in medical devices.
• Experience in FDA-regulated and ISO 13485 environments.
• Strong leadership and cross-functional collaboration skills.
• Expertise in risk management, validation, investigations, and CAPA.

Responsibilities

• Lead quality engineering activities supporting product development, design transfer, manufacturing, and post-market activities.
• Serve as a quality representative on cross-functional project teams for new product introductions, process changes, and manufacturing transfers.
• Provide technical leadership for process validation activities, including IQ, OQ, PQ, and continued process verification.
• Lead root cause investigations and ensure effective CAPA implementation.
• Facilitate risk management activities including Hazard Analysis, FMEA, risk assessments, and risk-benefit evaluations.
• Develop and maintain quality and inspection plans and process monitoring methodologies.
• Analyze quality metrics to identify trends and drive improvement.
• Support development, qualification, and validation of test methods and inspection systems.
• Partner with Manufacturing, R&D, Supply Chain, Regulatory Affairs, and Operations to resolve quality issues.
• Lead internal and external audits including FDA, ISO audits, customer audits, and supplier assessments.
• Review and approve engineering changes, nonconformances, deviations, validations, and quality documentation.
• Support supplier quality initiatives including supplier qualification and supplier audits.
• Provide statistical methods oversight including SPC, sampling plans, and data-driven decisions.
• Mentor Quality Engineers and guide on quality tools and regulations.
• Act as SME on quality system requirements and compliance expectations.

Skills

Quality engineering

Regulatory compliance (FDA/ISO 13485)

Root cause analysis

CAPA

Risk management

Process validation

Statistical methods (SPC)

Mentoring/leadership

Design transfer

Audits (FDA/ISO)

Education

Bachelor's degree in Engineering/Quality/Life Sciences

Master's degree (preferred)

Tools

QMS

CAPA systems

Process validation tools

Job description

EPM Scientific is seeking a Principal Quality Engineer to provide strategic and hands-on leadership across product development, manufacturing, and quality systems. You will drive risk management, CAPA, and process validation while ensuring compliance with FDA regulations and ISO 13485.

You will mentor engineers, lead cross-functional teams, and oversee audits, inspections, and quality documentation to support post-market activities and supplier quality initiatives in a fast-paced environment.