This job listing has expired and the position may no longer be open for hire.

Supplier Quality Auditor at 3M Healthcare US Opco LLC

Posted in General Business 30+ days ago.

Type: Full-Time
Location: Maplewood, Minnesota





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:

Supplier Quality Auditor (Solventum)

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
We are seeking a Quality Auditor to join our Solventum Global Supplier Quality team. The Supplier Quality Auditor will be responsible for assessing, evaluating and ensuring that our suppliers comply with industry regulations, quality standards, and company requirements. This role is critical in maintaining the integrity of the Quality of our supplied materials, continuity of our supply chain and ensuring delivery of better, smarter, safer healthcare products to improve patients' lives.

As a Supplier Quality Auditor, 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:

Conducting Supplier Audits:


  • Evaluate suppliers' quality management systems, processes, and documentation to ensure compliance with industry regulations (e.g., ISO 13485, FDA, EU MDR).

  • Prepare detailed audit reports, identifying non-conformances, and recommend corrective actions.

  • Hold Suppliers accountable for timely audit response and non-conformance resolution.

  • Ensure suppliers adequately convert Voice of Customer Expectations into aligned internal specifications.


Executing Supplier Qualification and Assessment:

  • Assess potential new suppliers to determine their capability to meet supplied material requirements and specifications to company standards.

  • Regularly reassess existing suppliers to ensure continued compliance and consistent performance.


Issue Resolution and Continuous Improvement:

  • Collaborate with suppliers to resolve audit findings and ensure timely implementation of corrective and preventive actions (CAPA).

  • Monitor the effectiveness of implemented CAPA and drive continuous improvement initiatives.

  • Work cross-functionally to ensure the appropriateness of proposed corrective action plans from suppliers prior to acceptance and implementation.


Documenting and Reporting:

  • Maintain accurate and up-to-date records of all audit activities, findings, and follow-up actions.

  • Prepare and present audit summaries and performance metrics to senior management.


Collaboration and Communication:

  • Work closely with cross-functional teams including Procurement, Quality Assurance, Regulatory Affairs, and Product Development to ensure supplier quality requirements are met.

  • Provide guidance and support to suppliers on quality standards and regulatory requirements.

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 Degree or higher from a four-year accredited college or university along with minimum of 5 years of experience in a quality-related auditing role in a regulated industry.

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


  • Certified Lead Auditor from an accredited agency (AAMI, ASQ, ISO, etc.), ISO 13485 preferred.

  • In-depth knowledge of industry standards and regulations (Ex: ISO 13485, ISO 9001, ISO 17025, FDA, CFR, EU MDR).

  • Strong analytical, root-cause analysis, and problem-solving skills.

  • Excellent English written and verbal communication skills.

  • Ability to work independently and manage multiple projects simultaneously.

  • Proficiency in Microsoft Office Suite and quality management software.

Additional qualifications that could help you succeed even further in this role include:


  • Bachelor's Degree in Engineering, Life Science, or other Manufacturing-related discipline along with 10 years of supplier quality auditing experience within the Healthcare Industry.

  • Advanced degree or certification in quality management (e.g., CQE, CQA).

  • Familiarity with GMP, Product and Process Controls.

  • Familiarity with Design Controls to include Design verification/validation.

  • Familiarity with Design of Experiment (DOE) Methodology.

  • Experience in navigating various ERP & QMS Software Systems (SAP, Oracle, MES, etc).

Work location:

  • Remote

Travel: May include up to 75% Domestic, %5 International

Relocation Assistance: Not Authorized.

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.

Applicable to US Applicants Only:The expected compensation range for this position is $119,076 - $145,537, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate's relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: https://www.solventum.com/en-us/home/our-company/careers/#Total-Rewards

Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.

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.

Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.

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.





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