Global Quality Compliance Engineer - QMS & Regulatory

SGP KCI Medical Asia Pte. Ltd.; Singapore; Hybrid; SGD 70,000 - 90,000; Full time

Job summary

Solventum is seeking a Quality Compliance Engineer to support the local Quality Management System (QMS) and regulatory compliance across the company, aligning with Healthcare Business Group standards and country requirements.

You will monitor SOPs, drive CAPA actions, support audits (internal, external, supplier and regulatory), and coordinate with cross-functional teams to strengthen governance and internal controls, ensuring timely corrective actions and sustained compliance.

Qualifications

• Bachelor’s degree in Pharmaceutical, Pharmacy or Science or equivalent.
• Analytical skill with ability to interpret data for routine operations.
• Knowledge of ISO 9001:2015 and ISO 13485:2016 or GDP/GDPMD.
• 2–5 years’ experience in Quality function.
• Certified ISO 13485 or GDPMD internal auditor preferred.
• Project management experience preferred.

Responsibilities

• Support local QMS with regulatory compliance across the company.
• Prepare, review, update, track, implement and monitor SOPs.
• Assist deployment of corporate policy to country local QMS.
• Coordinate with cross-functional teams on regulatory guidance for operations.
• Support audit activities (internal, external, supplier, regulatory).
• Lead CAPA in board meetings and ensure timely follow-up and effectiveness.

Skills

Analytical skills

ISO 13485

GDPMD

Education

Bachelor’s degree in Pharmaceutical, Pharmacy or Science

Job description

Solventum is seeking a Quality Compliance Engineer to support the local Quality Management System (QMS) and regulatory compliance across the company, aligning with Healthcare Business Group standards and country requirements.

You will monitor SOPs, drive CAPA actions, support audits (internal, external, supplier and regulatory), and coordinate with cross-functional teams to strengthen governance and internal controls, ensuring timely corrective actions and sustained compliance.