Quality Compliance Engineer - Hybrid (Singapore)

Solventum (3M Healthcare); Singapore; Hybrid; SGD 60,000 - 100,000; Full time

Job summary

Solventum Singapore seeks a Quality Compliance Engineer to strengthen regulatory and quality processes in a multi-site healthcare environment. You will support QMS implementation, SOP maintenance, and cross-functional collaboration to ensure compliant operations and customer satisfaction.

The role involves coordinating audits (internal, external, supplier, regulatory), CAPA follow-up and training activities, with up-to-date knowledge of ISO 9001/13485 and GDP/GDPMD.

Qualifications

• Bachelor's degree in Pharmaceutical, Pharmacy or Science or equivalent.
• Analytical skills to interpret data for routine operations.
• Solid understanding of ISO 9001:2015, ISO 13485:2016 or GDP/GDPMD.
• 2–5 years’ experience in Quality function.
• Certified ISO 13485 or GDPMD internal auditor is preferred.
• Experience with project management is preferred.

Responsibilities

• Support implementation, monitoring and improving local Quality Management System (QMS) with regulatory compliance across the company in alignment with Healthcare Business Group corporate quality standards and country regulatory requirements
• Prepare, review, update, track implement and monitor compliance of standard operating procedures
• Support Quality team in deployment of corporate policy to country local QMS
• Work closely with cross-functional teams in overseeing and providing regulatory/compliance guidance on operational activities (including customer complaints handling and supplier/subcon management)
• Support audit(s) activities including internal audit, external audit, supplier audit and regulatory audit
• Participate in CAPA board meeting to ensure corrective and preventive action is meeting corporate and country regulatory requirements. Ensure timely follow-up, execution, completion of necessary action and review effectiveness of CAPA.
• Support quality compliance improvement programs/projects
• Work closely with Management team to improve internal control and governance practices to enhance the effectiveness and efficiency of the operations and process to ensure compliance
• Serve as the point of the contact in the country on quality compliance matter
• Conduct and support training activities to cross-functional team in the country in alignment with corporate QMS requirements
• Support regional Quality Compliance leader to drive and implement any improvement project in country
• Issue CAPA based on audit findings and follow up through until closure
• Ensure CAPA effectiveness
• Conduct and support activity related to Field Corrective Action (FCA). Ensure timely follow-up, execution and completion of necessary action
• Plan and conduct audit(s) on subcon activity regularly to ensure effectiveness of QMS
• Identify requirements and establish the process for Issue Review and Escalation to division
• Leads the Identify and Assess steps within the Issue Review portion of this process. Responsible for documentation and obtaining approvals of the Issue Review Document
• Responsible for the investigation in issue review
• Other such duties that may be determined by management.

Skills

Analytical skills

Regulatory knowledge

Quality management

ISO 9001 / ISO 13485

Auditing

Education

Bachelor's degree in Pharmaceutical, Pharmacy or Science

Job description

Solventum Singapore seeks a Quality Compliance Engineer to strengthen regulatory and quality processes in a multi-site healthcare environment. You will support QMS implementation, SOP maintenance, and cross-functional collaboration to ensure compliant operations and customer satisfaction.

The role involves coordinating audits (internal, external, supplier, regulatory), CAPA follow-up and training activities, with up-to-date knowledge of ISO 9001/13485 and GDP/GDPMD.