Quality Compliance Engineer,SGP

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.

1. 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

2. Prepare, review, update, track implement and monitor compliance of standard operating

procedures

3. Support Quality team in deployment of corporate policy to country local QMS

4. Work closely with cross-functional teams in overseeing and providing regulatory/compliance

guidance on operational activities (including customer complaints handling and

supplier/subcon management)

5. Support audit(s) activities including internal audit, external audit, supplier audit and regulatory

audit

6. 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.

7. Support quality compliance improvement programs/projects

8. 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

9. Serve as the point of the contact in the country on quality compliance matter

10. Conduct and support training activities to cross-functional team in the country in alignment

with corporate QMS requirements

11. Support regional Quality Compliance leader to drive and implement any improvement project

in country

12. Issue CAPA based on audit findings and follow up through until closure

13. Ensure CAPA effectiveness

14. Conduct and support activity related to Field Corrective Action (FCA). Ensure timely follow-up,

execution and completion of necessary action

15. Plan and conduct audit(s) on subcon activity regularly to ensure effectiveness of QMS

16. Identify requirements and establish the process for Issue Review and Escalation to division

17. 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

18. Responsible for the investigation in issue review

19. Other such duties that may be determined by management.

• 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

• 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

Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms.

Please access the linked document by clicking here. Before submitting your application you will be asked to confirm your agreement with the
terms.