QC Team Leader

ResMed; Kulai; On-site; MYR 67,000 - 100,000; Full time

Job summary

ResMed is seeking a Manufacturing Quality Lead to design, implement, and monitor QC programs. You will ensure products meet specifications and regulatory requirements, report defects, and drive continuous improvement on the production floor.

The role involves leading QC Inspectors, training staff, managing calibration, and delivering KPI‑driven quality improvements across materials and processes. A tertiary engineering or science degree and GMP knowledge are essential.

Qualifications

• Tertiary qualification in Engineering or Science.
• Solid knowledge of FDA QSR, GMP, and ISO standards.
• Experience in volume manufacturing and leadership is preferred.

Responsibilities

• Lead QC Inspectors to meet daily operational goals.
• Train on procedures and product specifications; maintain LMS training records.
• Mentor team members and coordinate skills improvement.
• Build strong cross‑functional relationships and support global projects.
• Support calibration team to maintain calibration systems.
• Oversee QC processes for incoming, in‑process, and outgoing checks.
• Resolve daily QC issues with sound problem‑solving techniques.
• Maintain records; ensure proper filing and archiving.
• Drive investigations and dispositions for nonconforming materials.
• Provide monthly KPI tracking, including SPC analysis.

Skills

GMP knowledge

Quality systems

Regulatory compliance

Root cause analysis

Leadership

Cross-functional collaboration

MS Office / Oracle

Education

Engineering or Science degree

Tools

Microsoft Office

Oracle

Quality Management Systems (QMS)

Job description

Job Description

The primary role of Manufacturing Quality function is to design, implement and monitoring quality control programs. Key deliverables include, but not limited to, recommending changes to methods, procedures and standards to improve quality of output based on analysis of data and systems. Ensures products are built correctly to specification, quality standards and appropriate regulatory compliance. Reports defects and tracks until resolution.

Key Responsibilities

Team Leadership

• Lead, motivate, and support QC Inspectors to meet daily operational goals.
• Conduct training on procedures and product specifications; maintain LMS training records.
• Mentor team members, identify development opportunities, and coordinate skills improvement.
• Build strong working relationships with cross‑functional teams.
• Ability to lead and support global projects or continuous improvement projects.
• Support the calibration team in maintaining calibration systems and driving improvement.

QC Inspection & Reporting

• Oversee QC processes for incoming materials, in‑process checks, and outgoing checks.
• Resolve daily QC issues using sound problem‑solving techniques.
• Ensure records are properly maintained, filed, and archived without backlog.
• Manage nonconforming materials and drive timely investigations and dispositions.
• Improve QC processes and provide monthly KPI tracking, including SPC analysis.

Safety

• Support rehabilitation of injured employees and uphold Duty of Care obligations.
• Promote safe work practices and prevent OH&S hazards, especially around manual handling.

GMP & Housekeeping

• Ensure GMP, 5S, and quality standards are consistently followed on the production floor.

Qualifications & Experience

Core Competencies

• Strong understanding of GMP, quality systems, and regulatory requirements.
• Ability to maintain process documentation and ensure product traceability.
• Strong analytical capability for root cause and corrective action analysis.
• Effective communication, leadership, and cross‑functional collaboration.
• Able to manage multiple priorities with attention to detail.
• Proficient in Microsoft, Oracle, and relevant software tools.

Required

• Tertiary qualification in Engineering or Science.
• Minimum 2 years of industrial experience, preferably in volume manufacturing.
• Solid knowledge of FDA QSR, GMP, and ISO standards.

Preferred

• Experience managing people or leadig teams.

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates.