Quality Engineer

Cypress HCM; Irvine (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

Cypress HCM is seeking a Senior Quality Engineer in Irvine, California, to support and improve quality systems for regulated products. The role involves collaborating with various teams to ensure compliance with quality standards and driving continuous improvement.

The ideal candidate will have 3+ years of experience in Quality Engineering within regulated fields like medical devices or pharmaceuticals, along with expertise in CAPA and Quality Systems.

Qualifications

• 3+ years of Quality Engineering experience within a regulated industry.
• Strong knowledge of Quality Systems, CAPA, and Nonconformance Management.
• Experience supporting FDA, ISO 13485, ISO 9001.

Responsibilities

• Support and maintain Quality Management System (QMS) processes.
• Lead investigations related to nonconformances and CAPAs.
• Analyze quality metrics for process improvement.

Skills

Quality Systems

CAPA

Root Cause Analysis

Statistical Methods

Cross-functional Collaboration

Education

Bachelor's degree in Engineering, Quality, Life Sciences, or related technical discipline

Tools

Minitab

Job description

We are seeking a Senior Quality Engineer to play a critical role in maintaining and improving quality systems supporting the development and manufacture of highly regulated products. This position partners closely with Manufacturing, Operations, Engineering, Supply Chain, and Regulatory teams to ensure compliance with quality standards while driving continuous improvement throughout the organization.

This is an excellent opportunity for a quality professional who thrives in a fast-paced environment and enjoys balancing hands‑on problem solving with strategic quality initiatives.

Responsibilities

• Support and maintain Quality Management System (QMS) processes in accordance with applicable regulatory requirements and internal procedures.
• Lead investigations related to nonconformances, deviations, complaints, and CAPAs.
• Analyze quality metrics and trends to identify opportunities for process improvement and risk reduction.
• Develop, implement, and improve incoming, in-process, and final inspection procedures.
• Review and approve quality records, specifications, procedures, and other controlled documentation.
• Collaborate with Manufacturing and Engineering teams to resolve quality issues and implement corrective actions.
• Support equipment qualification and process validation activities, including IQ, OQ, and PQ protocols.
• Participate in design transfer, manufacturing scale‑up, and process improvement initiatives.
• Conduct root cause analysis using structured problem‑solving methodologies.
• Support internal, customer, supplier, and regulatory audits.
• Train personnel on quality procedures, GMP requirements, and quality best practices.

Supplier Quality Responsibilities

• Perform supplier qualification and supplier audits.
• Manage supplier corrective action requests (SCARs) and monitor effectiveness.
• Maintain and improve Approved Supplier List (ASL) processes.
• Evaluate supplier performance through quality metrics and scorecards.
• Partner with suppliers to improve quality, delivery, and compliance.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or related technical discipline.
• 3+ years of Quality Engineering experience within a regulated industry such as medical device, biotechnology, diagnostics, pharmaceutical, or aerospace manufacturing.
• Strong knowledge of Quality Systems, CAPA, Nonconformance Management, Change Control, and Risk Management.
• Experience supporting FDA, ISO 13485, ISO 9001, or other regulated quality environments.
• Experience with process validation and equipment qualification activities (IQ/OQ/PQ).
• Strong understanding of statistical methods and quality tools.
• Experience conducting root cause investigations and implementing effective corrective actions.
• Excellent communication and cross‑functional collaboration skills.

Preferred Qualifications

• ASQ Certified Quality Engineer (CQE) or equivalent certification.
• Experience supporting supplier quality programs.
• Knowledge of Minitab or other statistical analysis tools.
• Experience participating in FDA, Notified Body, or customer audits.