Director, Quality Systems & Compliance

Masimo Medical Technologies (Malaysia) Sdn. Bhd.; Irvine (CA); On-site; USD 170,000 - 210,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k)

Job summary

Masimo Medical Technologies (Malaysia) Sdn. Bhd. seeks a Director of Quality Systems to lead the global quality strategy and governance, ensuring regulatory compliance across the organization.

You will oversee CAPA, change control, document control, training, and metrics while building a high-performing team. The role partners with Regulatory, Engineering, Operations, Clinical, and IS teams to drive continuous improvement and readiness for inspections, audits, and product lifecycle quality

Qualifications

• 10+ years of progressive experience in Quality Assurance, Quality Systems or Quality Compliance within a regulated medical device or life sciences environment.
• 5+ years of leadership experience managing direct reports, managers, or cross-functional quality teams.
• Strong knowledge of Quality Management Systems (QMS) principles and regulated quality processes.
• Deep understanding of regulatory and industry requirements including FDA 21 CFR 820, 803/806, ISO 13485, EU MDR, and MDSAP.
• Experience leading HHE and nonconformance processes.
• Strong CAPA, change control, quality metrics, and process improvement experience.
• Ability to analyze quality data, trends, and performance indicators for risk-based decisions.
• Excellent communication and cross-functional collaboration skills.
• Ability to travel up to 5–10%.

Responsibilities

• Lead and oversee Quality Systems activities to ensure compliance with internal procedures and regulatory requirements.
• Provide strategic leadership for core Quality Systems processes, including HHE, nonconformance, metrics, and management review.
• Drive continuous improvement to strengthen QMS effectiveness, scalability, and efficiency.
• Monitor quality system performance through data analysis, KPI development, and trend reviews.
• Partner with Regulatory, Engineering, Manufacturing, Supply Chain, and Clinical teams to integrate QMS into lifecycle processes.
• Support internal, external, customer audits and regulatory inspections, ensuring readiness and timely corrective actions.
• Ensure QMS aligns with FDA, ISO, MDSAP and global medical device regulations.
• Develop, review, and approve policies and quality system documentation.
• Inform management of performance, risks, and improvement opportunities.

Skills

QMS knowledge

CAPA & change control

Regulatory knowledge

Leadership

Cross-functional collaboration

Data analysis

Project management

Communication skills

English proficiency

Education

Bachelor's degree in Engineering/Life Sciences/Quality or related

Master’s degree preferred

Tools

eQMS

Job description

Masimo Medical Technologies (Malaysia) Sdn. Bhd. seeks a Director of Quality Systems to lead the global quality strategy and governance, ensuring regulatory compliance across the organization.

You will oversee CAPA, change control, document control, training, and metrics while building a high-performing team. The role partners with Regulatory, Engineering, Operations, Clinical, and IS teams to drive continuous improvement and readiness for inspections, audits, and product lifecycle quality