QMS Coordinator (m/f/x)

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ applies to any personal information you submit. 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:

We are pleased to report that Solventum has successfully completed the sale of its Purification & Filtration (P&F) business to Thermo Fisher Scientific Inc. (Thermo Fischer). This is a significant milestone for the P&F business, allowing for the strategic investment and resources needed to sustain growth and deliver customer solutions. Please note that this position is scheduled to transfer to a local subsidiary of Thermo Fisher in your country. However, the position is in a country where the transfer of employees to Thermo Fisher is delayed until a later date. By joining Solventum during this transitional period, you will be able to work alongside an energized and mission-driven team who is experiencing this transition along with you. Until the transfer is complete, you will be employed by Solventum,  and your employment is subject to all applicable terms and conditions as outlined in our employment agreement and company policies.

The Impact You’ll Make in this Role

• Strengthening and maintaining a compliant and robust Quality Management System

• Ensuring high product quality and supporting a strong culture of compliance across the organization

• Playing a key role in preparing, coordinating, and actively participating in pharmaceutical customer audits, enhancing customer trust and satisfaction

• Supporting inspection readiness and contributing to successful outcomes during internal, customer, and regulatory audits

• Driving continuous improvement initiatives that optimize quality processes and enhance operational efficiency

• Providing quality oversight and cross-functional support to ensure that all activities meet  internal requirements

Preferred Qualifications

• Significant experience in preparing, coordinating, and actively participating in pharmaceutical customer audits (major role in documentation preparation, on‑site support, and follow‑up of audit findings)

• Practical experience supporting internal audits or external regulatory inspections

• Ability to manage and maintain quality documentation in accordance with compliance requirements

• Performing the function of an internal and external auditor

Your Skills and Expertise 

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

• Bachelor’s or Master’s degree in Pharmacy, Biotechnology, Chemistry, Quality Management, or a related scientific field

• Preferred 2–3 years of experience in Quality Assurance / Quality Systems within the pharmaceutical or medical device industry

• Strong knowledge ISO 9001

• Experience working with Quality Management Systems (Deviation Management, CAPA, Change Control, Document Control, Audits, Training).
   

AND

In addition to the above requirements, the following are also required:

• Experience with risk management tools (e.g., FMEA)

• Knowledge of validation, qualification, and data integrity principles

• Experience in supporting regulatory inspections and customer quality audits

• knowledge of GMP

• Ability to lead small quality improvement projects

• Excellent analytical thinking, problem‑solving abilities, and attention to detail

• Strong communication skills and ability to collaborate with cross-functional teams (QA, QC, Production, Engineering, Validation).

• Fluent English (written and spoken)

• Experience in using the SAP system is welcome

• Current, valid Driver’s License would be beneficial

Work location:

• Onsite - 4 day per week

• Wrocław, Kowalska/Kwidzyńska street (Purification and Filtration Division)

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

Supporting Your Well-being 

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

Diversity & Inclusion

(*) We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, gender, sexual orientation, age, civil status, disability, family status, or membership of the travelling community.

   

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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