Quality Compliance Engineer,SGP

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

At Solventum, we improve lives by helping healthcare professionals do their best work. Join a team using innovation and insight to make a real impact on the future of healthcare. All roles listed are with Solventum, and we're committed to protecting your personal information-learn more in our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/

Job Description:

3M Health Care is now Solventum

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.

We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

The Impact You'll Make in this Role

As a Quality Compliance Enginner, you will handle customer service inquiries of moderate scope and complexity, including customer inquiry support, issue resolution, distributor order management, account support, and customer service analytics. You will also coordinate with supply chain and other internal teams to support order fulfillment and provide a positive customer experience.

Key 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.

Your Skills and Expertise

• Bachelor's degree in Pharmaceutical, Pharmacy or Science or equivalent
• Has analytical skill, able to interpret information and data for routine operational needs.
• Has good understanding on ISO9001:2015, ISO 13485:2016 or GDP/GDPMD
• Minimum 2-5 years' experience in Quality function
• Certified ISO 13485 or GDPMD internal auditor is preferred
• Experience with project management is preferred

Work Location: Singarpore

Hybrid Eligible

This position follows a hybrid working arrangement, combining office-based work in Shanghai with remote work from home, subject to business needs and company policies.

Travel: May include up to 5% domestic travel

Supporting Your Well-being

Solventum offers programs to support employees' physical and financial well-being. We regularly benchmark our compensation and benefits with companies of comparable size and scope.