Job Description

3M has a long-standing reputation as a company committed to innovation. We provide the freedom to explore and encourage curiosity and creativity. We gain new insight from diverse thinking, and take risks on new ideas. Here, you can apply your talent in bold ways that matter.

:

Asia Quality Compliance Specialist (New Health Care Company)

3M is establishing two industry-leading companies, creating value through the spin-off of its Health Care business, while 3M will continue to be a global material science leader, focusing our innovation to win in favorable global megatrends and attractive end markets. This new Health Care Company will be a leading global diversified health technology company with:

• Proven category leadership
• Exposure to attractive end-markets

• Innovation mindset driving improved patient outcomes
• Collaborative customer relationships
• Deep global regulatory experience
• Operational excellence and strong cash flow
• Strong sales growth and profitability with significant recurring sales

We expect the creation of the two companies will be completed by the end of 2023. For now, we will continue to operate as one global company. This role is positioned to drive the success of the "New Health Care Company\xe2\x80\x9d.

Responsibilities:

• Ensure 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
• Support SEA country compliance specialist in daily operation
• Other such duties that may be determined by management.

Your Skills and Expertise

To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications:

• Bachelor\xe2\x80\x99s degree or higher in Pharmaceutical, Pharmacy or Science or equivalent

• Minimum 5-10 years of experience in Quality function in a private, public, government or military environment
• Has analytical skill, able to interpret information and data for routine operational needs.
• Has good understanding on ISO 13485:2016 or GDP/GDPMDs
• Certified ISO 13485 or GDPMDS internal auditor is preferred
• Experience with project management is preferred

For current employees, internal transfer restrictions may not apply. For more details, contact your local recruiter/HR team.

Work location:

• Work Your Way Eligible (Employee choice to work remote, on site, or hybrid)
• Hybrid Eligible (Job Duties allow for some remote work but require travel to Techpoint AMK at least 1 days per week)

Travel: May include up to 10% international

Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Supporting Your Well-being

3M offers many programs to help you live your best life \xe2\x80\x93 both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope.

Chat with Max

For assistance with searching through our current job openings or for more information about all things 3M, visit Max, our virtual recruiting assistant on 3M.com/careers.

Learn more about 3M\xe2\x80\x99s creative solutions to the world\xe2\x80\x99s problems at www.3M.com or on Twitter @3M.

Our approach to flexibility is called Work Your Way, which puts employees first and drives well-being in ways that enable 3M\xe2\x80\x99s business and performance goals. You have flexibility in where and when work gets done. It all depends on where and when you can do your best work.

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.

3M Global Terms of Use and Privacy Statement

Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at 3M are conditioned on your acceptance and compliance with these terms.

Please access the linked document by clicking select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with the terms.

3M