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Solventum

Quality Compliance Engineer ( New Health Care Company)

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Job Description

Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ continues to apply to any personal information you submit, and the 3M-branded positions listed on our Careers Page are for Solventum positions. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Job Description:


3M Healthcare 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.

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:

Bachelors 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: Singapore

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

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 both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in 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.

Solventum 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 Solventum are conditioned on your acceptance and compliance with these terms.

Please access the linked document by clicking here, 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.

More Info

Industry:Other

Function:Healthcare

Job Type:Permanent Job

Skills Required

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Date Posted: 23/10/2024

Job ID: 97624959

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