Quality Compliance Engineer

About the role

Solventum (formerly 3M Health Care) is hiring a Quality Compliance Engineer in Singapore. The role handles customer service inquiries of moderate scope and complexity, including inquiry support, issue resolution, distributor order management, account support and customer service analytics, and coordinates with supply chain and other internal teams to support order fulfilment. It is a hybrid position with office-based work combined with remote work, and may include up to 5% domestic travel.

Key responsibilities

• Support the implementation, monitoring and improvement of the local Quality Management System (QMS) in line with corporate quality standards and country regulatory requirements.
• Prepare, review, update, track and monitor compliance of standard operating procedures.
• Support the Quality team in deploying corporate policy to the country's local QMS.
• Provide regulatory and compliance guidance to cross-functional teams, including customer complaints handling and supplier/subcontractor management.
• Support internal, external, supplier and regulatory audits, and plan regular audits of subcontractors.
• Issue CAPA based on audit findings, follow them through to closure and ensure their effectiveness.
• Participate in CAPA board meetings and support Field Corrective Action (FCA) activities.
• Lead the identify and assess steps of the issue review process, including documentation and approvals, and investigate issues.
• Establish the process for issue review and escalation to the division, and serve as the country point of contact for quality compliance matters.
• Conduct and support training for cross-functional teams on corporate QMS requirements, and support improvement projects with the regional Quality Compliance leader.

Required profile

• Bachelor's degree in Pharmaceutical, Pharmacy or Science, or equivalent.
• Minimum 2-5 years of experience in a Quality function.
• Analytical skills, able to interpret information and data for routine operational needs.
• Certified ISO 13485 or GDPMD internal auditor preferred; experience with project management preferred.

Required skills

• Good understanding of ISO 9001:2015, ISO 13485:2016 or GDP/GDPMD.