Principal Quality Engineer

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

The Principal Quality Engineer serves as a technical leader within the Quality organization, providing strategic and hands‑on support for product development, manufacturing operations, process validation, and quality system compliance. This role partners with cross‑functional teams to ensure products are designed, manufactured, and maintained in compliance with FDA regulations, ISO 13485 requirements, and company quality standards.

The Principal Quality Engineer will lead complex quality initiatives, drive continuous improvement efforts, mentor engineering staff, and act as a subject matter expert for risk management, validation, investigations, and quality systems.

Essential 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 using structured problem‑solving methodologies and ensure effective implementation of corrective and preventive actions (CAPA).
• Facilitate risk management activities including Hazard Analysis, FMEA, risk assessments, and risk‑benefit evaluations.
• Develop and maintain quality plans, control plans, inspection strategies, and process monitoring methodologies.
• Analyze quality metrics and process performance data to identify trends and drive continuous improvement initiatives.
• 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 and improve product performance.
• Lead internal and external audits, including FDA inspections, 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, supplier audits, performance monitoring, and supplier corrective actions.
• Provide technical oversight of statistical methods including SPC, process capability analysis, sampling plans, and data‑driven decision making.
• Mentor Quality Engineers and provide guidance on quality tools, regulations, and best practices.
• Act as a subject matter expert on quality system requirements and compliance expectations.

Position Summary

The Principal Quality Engineer serves as a technical leader within the Quality organization, providing strategic and hands‑on support for product development, manufacturing operations, process validation, and quality system compliance. This role partners with cross‑functional teams to ensure products are designed, manufactured, and maintained in compliance with FDA regulations, ISO 13485 requirements, and company quality standards.

The Principal Quality Engineer will lead complex quality initiatives, drive continuous improvement efforts, mentor engineering staff, and act as a subject matter expert for risk management, validation, investigations, and quality systems.

Essential 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 using structured problem‑solving methodologies and ensure effective implementation of corrective and preventive actions (CAPA).
• Facilitate risk management activities including Hazard Analysis, FMEA, risk assessments, and risk‑benefit evaluations.
• Develop and maintain quality plans, control plans, inspection strategies, and process monitoring methodologies.
• Analyze quality metrics and process performance data to identify trends and drive continuous improvement initiatives.
• 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 and improve product performance.
• Lead internal and external audits, including FDA inspections, 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, supplier audits, performance monitoring, and supplier corrective actions.
• Provide technical oversight of statistical methods including SPC, process capability analysis, sampling plans, and data‑driven decision making.
• Mentor Quality Engineers and provide guidance on quality tools, regulations, and best practices.
• Act as a subject matter expert on quality system requirements and compliance expectations.

Qualifications

Education

• Bachelor's degree in Engineering, Quality, Life Sciences, or related technical discipline required.
• Master's degree preferred.

Experience

• 10+ years of quality engineering experience within the medical device industry.
• Experience working within FDA‑regulated and ISO 13485‑certified environments.
• Demonstrated experience supporting manufacturing processes and product development activities.
• Experience leading complex quality initiatives and cross‑functional projects.
• Prior experience serving as a technical mentor or informal leader preferred.