Principal Quality Engineer

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

Job summary

EPM Scientific in California seeks a Principal Quality Engineer to lead quality initiatives across product development, manufacturing, and post-market activities. You will provide strategic guidance and hands-on support in risk management, validation, CAPA, and quality systems to ensure FDA and ISO 13485 compliance.

You will mentor engineering staff, collaborate with R&D, manufacturing, regulatory affairs, and supply chain to resolve issues, drive process improvements, and support audits,

Qualifications

• 10+ years of quality engineering experience in the medical device industry.
• Experience in FDA-regulated and ISO 13485-certified environments.
• Experience leading complex quality initiatives and cross-functional projects.
• Design transfer, manufacturing support, and post-market activities.

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 and process changes.
• Provide technical leadership for process validation activities (IQ, OQ, PQ, and VP).
• Lead root cause investigations and ensure CAPA effectiveness.
• Facilitate risk management activities including Hazard Analysis, FMEA, and risk assessments.
• Develop and maintain quality plans, control plans, and inspection strategies.
• Lead internal and external audits including FDA inspections and ISO audits.
• Review and approve engineering changes, nonconformances, deviations, and quality documentation.

Skills

Quality engineering

Risk management

CAPA

Process validation

Statistical methods

Root cause analysis

Cross-functional leadership

Mentoring

FDA regulations

Education

Bachelor's degree in Engineering/Quality/Life Sciences

Master's degree preferred

Tools

Statistical software (Minitab/JMP)

Process capability analysis

Sampling plans

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.

• 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.