Job Description: Site Quality Manager, Solventum Monterrey, Mexico 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 Site 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:
Standing up new Quality Management Systems (QMS) for a new medical device manufacturing site, and obtaining ISO 13485 certification.
Ensuring the suitability and effectiveness of transferred test methods, Device Master Records (DMR), calibration, and other documents and records.
Hiring and training the Quality Team.
Participating in site Leadership Team ensure the training programs, master validation plan, software qualification and equipment & facility maintenance plans are suitable and effective.
Preparing for, managing, and following-up on quality and regulatory audits/inspections conducted by external agencies, notified bodies, customers, and internal functions.
Your Skills and Expertise
To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:
Bahcelor´s degree in the pharmaceutical, chemical, biological, medicine, biomedical, biochemistry or other profession, as long as it is related to the process; degree and professional license issued and registered by the competent educational authorities
Seven (7) years Regulatory, Quality and/or QMS experience within a heath care regulated industry at a private, public, government, or military environment.
Fluent written and oral communication in both English and Spanish.
Three (3) years supervisory experience.
Additional qualifications that could help you succeed even further in this role include:
Previous experience establishing a new QMS.
Proven ability to lead audit activities
Lean, Six Sigma, and/or Project Manager certification
Work location: Guadalupe, Monterrey (Onsite) Travel: May include up to 10% domestic and international
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status). 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.
Solventum es un empleador que ofrece las mismas oportunidades. 3M no discriminará a ningún solicitante de empleo por razones de raza, color, edad, religión, sexo, orientación sexual, identidad o expresión de género, origen nacional, discapacidad o estado de veterano.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
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Our Story 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 continue 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 q ualified 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. At Solventum, we create breakthrough solutions for our customers' toughest challenges by pioneering game-changing innovations at the intersection of health, material and data science to change patients' lives for the better — while enabling healthcare professionals to perform at their best.
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