Quality Compliance Engineer

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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

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.

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.

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process.  Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.

Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.

Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.

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