Quality Manager India

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 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 Manager, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

• Ensuring local regulatory and quality compliance are met.
• Ensuring compliance with local regulation and Solventum requirements, including post-market surveillance, labelling, QMS maintenance, and storage & distribution of product to customers.
• Managing the post-market activities such as product complaints, field actions, and adverse event reporting, ensuring compliance with standards.
• Maintaining the necessary quality certification (eg ISO 13485) of Solventum India.
• Leading and driving the accountability of India Quality Management System (QMS) ensuring the effectiveness of the QMS.
• Leading quality activities, including internal audits, supplier audits, BPQN / CAPA, Quality Management Review meetings, QMS training. Ensuring proper maintenance of quality documents and records.
• Overseeing the quality management system of 3PL to meet internal and external requirements, including product labelling, storage, and distribution control.
• Responsible for the local labelling process to ensure regulatory compliance and meeting the Solventum quality requirements.
• Overseeing quality processes of service & repair centres, distributors, subcontractors, including but not limited to the selection, qualification, audits, and monitoring.
• Providing work direction & oversight, team prioritization, and collaboration with key cross-functional partners.

• Leading and driving proactive efforts to identify opportunities and projects to optimise and improve processes.
• Providing direct supervision to assigned direct reports through leadership, coaching, training, development, allocating work assignment, review of progress in achieving objectives.
• Leading the Solventum QMS deployment & implementation by mitigating non-compliant risks, performing gap analysis, reviewing and alignment of local processes with global processes.
• Planning and managing the resource allocation, expense of the India quality team per the approved budget
• Alerting senior and/or executive management of significant quality, and compliance risks.

Your Skills and Expertise 
 

To set you up for success in this role from day one, Solventum requires:

• Bachelor’s Degree or higher
• Fluent in English
• Seven (7) years combined in Medical Device and/or pharmaceutical experience in Quality with at least three (3) years in the commercial distribution quality role.
• Three (3) years of pharmaceutical experience working with cGMP regulations will be an advantage
• Three (3) years in a people management role
•  ISO13485 certification as an auditor is preferred
• Good communication skills, written and oral
• Largely self-managed with ability to communicate upwards and cross functionally to ensure all key projects / deliverables are met.

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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