Senior Quality Engineer

Cypress HCM; Irvine (CA); On-site; USD 100,000 - 130,000; Full time

Job summary

Cypress HCM is seeking a Quality Engineering Manager located in Irvine, California, to lead and mentor a team of engineers. The candidate should have over 7 years of experience in the medical device industry, ensuring compliance with FDA regulations and implementing quality standards across processes.

The role requires strong leadership skills to drive quality initiatives and effectively communicate across various teams, with a focus on continuous improvement using Lean and Six Sigma practices.

Qualifications

• 7+ years of experience in Quality Engineering, especially in the medical device industry.
• 2+ years of leadership or project management experience.
• Proven record in leading audits and CAPA investigations.

Responsibilities

• Lead and mentor a team of Quality Engineers.
• Ensure compliance with FDA and ISO regulations.
• Drive investigations related to quality nonconformances.

Skills

Quality Engineering

FDA regulations knowledge

Leadership

Problem-solving methodologies

Lean Six Sigma practices

Education

Bachelor's degree in Engineering

Job description

Responsibilities

• Lead and mentor a team of Quality Engineers, providing technical guidance, performance management, and career development.
• Oversee quality engineering activities supporting manufacturing, product development, supplier quality, and sustaining engineering efforts.
• Ensure compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and applicable international regulations.
• Drive investigations related to nonconformances, deviations, complaints, and CAPAs while ensuring timely and effective resolution.
• Lead root cause analysis efforts using structured problem‑solving methodologies and implement corrective and preventive actions.
• Review and approve quality documentation, engineering changes, validation protocols, risk assessments, and design control deliverables.
• Oversee process validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Partner with Manufacturing, Operations, R&D, Regulatory Affairs, and Supply Chain teams to drive quality improvements and operational excellence.
• Support new product introductions, manufacturing transfers, and process improvement initiatives.
• Establish and monitor key quality metrics and drive data‑based decision‑making across the organization.
• Lead internal audits, supplier audits, and support FDA inspections, ISO audits, and regulatory submissions.
• Ensure effective supplier quality management processes including supplier qualification, performance monitoring, and risk mitigation.
• Champion continuous improvement initiatives utilizing Lean, Six Sigma, and quality engineering best practices.

Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• 7+ years of Quality Engineering experience within the medical device industry.
• 2+ years of leadership, supervisory, or project leadership experience.
• Strong working knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, CAPA systems, risk management, and design controls.
• Experience supporting Class II and/or Class III medical devices.
• Proven experience leading investigations, CAPAs, audits, and validation programs.
• Experience with IQ, OQ, and PQ development, execution, and approval.
• Strong understanding of manufacturing processes, process validation, and quality systems.
• Excellent communication, leadership, and stakeholder management skills.

Preferred Qualifications

• Experience supporting diabetes management, drug delivery, wearable medical devices, or connected health products.
• ASQ Certified Quality Engineer (CQE), Certified Quality Manager (CQM), or equivalent certification.
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience in a high‑growth medical device environment.
• Experience supporting global regulatory inspections and supplier networks.