Quality Manager, Baby Products (ISO 13485)

Hegen; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Hegen in Singapore is seeking a Quality Manager to lead QA across design, manufacturing and supplier quality for infant feeding products. You will implement ISO 13485-aligned QMS, drive CAPA, analytics and cross‑functional improvements with R&D, Production, Supply Chain and Customer Success.

You will mentor the quality team, manage audits, ensure product safety and regulatory compliance, and partner with manufacturing to reduce defects and improve yield in a fast-paced environment.

Qualifications

• Bachelor's degree in Mechanical/Manufacturing/Quality or equivalent.
• At least 5 years in manufacturing QA with plastics moulding.
• Experience implementing or auditing ISO 13485 QMS.
• Strong knowledge of SPC, FMEA and CAPA.

Responsibilities

• Develop, implement and maintain a QMS aligned with ISO 13485 and regulatory requirements.
• Oversee product quality across lifecycle from design to after-sales.
• Lead supplier quality management and audits; drive CAPA and corrective actions.
• Coordinate manufacturing quality controls across moulding, assembly and packing.
• Lead and develop the Quality team and drive Lean/Six Sigma improvements.

Skills

Quality management

ISO 13485

Lean Six Sigma

Root cause analysis

Stakeholder management

Leadership

Analytical thinking

Education

Bachelor's degree in Mechanical/Manufacturing/Quality or equivalent

Tools

QMS software

MS Office

SPC tools

Job description

Hegen in Singapore is seeking a Quality Manager to lead QA across design, manufacturing and supplier quality for infant feeding products. You will implement ISO 13485-aligned QMS, drive CAPA, analytics and cross‑functional improvements with R&D, Production, Supply Chain and Customer Success.

You will mentor the quality team, manage audits, ensure product safety and regulatory compliance, and partner with manufacturing to reduce defects and improve yield in a fast-paced environment.