Principal Quality Engineer: MedTech Quality Leader

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

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,