Senior Quality Assurance Engineer at 3M Healthcare US Opco LLC in San Antonio, Texas

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/ 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:

Senior Quality Assurance Engineer

3M is establishing two industry-leading companies, creating value through the spin - off of its Health Care business, while 3M will continue to be a global material science leader, focusing our innovation to win in favorable global megatrends and attractive end markets. This new Health Care Company will be a leading global diversified health technology company with:

• Proven category leadership


• Exposure to attractive end-markets


• Innovation mindset driving improved patient outcomes


• Collaborative customer relationships


• Deep global regulatory experience


• Operational excellence and strong cash flow


• Strong sales growth and profitability with significant recurring sales

We expect the creation of the two companies will be completed by the end of the first quarter of 2024. We will continue to operate as one global company. This role is positioned to drive the success of the "New Health Care Company".

The Impact You'll Make in this Role

As a Senior Quality Assurance Engineer, 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:

• Core team lead for Quality / Design Assurance on new product development teams for Negative Pressure Wound Therapy (NPWT) projects; quality team project manager to ensure product is developed meeting quality system processes and applicable regulations.


• Key liaison between core project teams and extended team, including but not limited to: Design Verification and Stability in preparing protocols/test methodologies, developing sample sizes, and establishing acceptance criteria; Post Market Surveillance team for preparing plans and reviewing data post launch; Complaint Handling for preparing technical support documents for new product introduction; Usability/Human Factors/Application Engineering (for design validation testing); Software Quality Assurance for software validation; Manufacturing Quality; and Supplier Quality for qualification of new components/assemblies and suppliers


• Ensures adherence to the Risk Management Process including development of Risk Management Plan, creation of applicable Risk Analyses, and development of Final Risk Management Report


• Develops Quality Plans for new products, research and document historical data (e.g. complaints, Corrective and Preventive Action (CAPAs), Service Data, Repair Data) for similar products/components and ensures quality objectives are defined and measurable.


• Reviews and approves all production release specifications, drawings, and labeling and ensures Critical to Quality characteristics and inspection characteristics are included on specifications/prints.


• Coordinates with Quality Assurance and Manufacturing Engineering to ensure organizational readiness for new components and/or assemblies (Activities include ensuring drawings/specifications are clear, availability of correct tools/equipment for inspection/test, and qualification of measurement/test methods)

Your Skills and Expertise

To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications:

• Bachelor's Degree or higher in an engineering discipline AND Five (5) years of design or quality engineering experience in a regulated industry

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

• Master's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or related discipline from an accredited institution (with Master's, min. 3 years' experience acceptable)


• Scientific knowledge and experience in product development of medical devices including knowledge in country regulations and standards applicable to medical device compliance, with one or more of the following:
  
  
  • International Organization for Standardization (ISO) 13485 Medical devices - Quality Management Systems (QMS)
  
  
  • Food and Drug Administration (FDA) Code of Federal Regulations (CFR) 820 Quality System Regulation, 820.30 Design Controls, 812 Investigational Device Exemptions (Clinical Study Product)
  
  
  • ISO 14971 Application of Risk Management to Medical Devices
  
  
  • European Union (EU) Medical Device Directive Regulation 2020
  
  
  • ISO 60601 Safety and Essential Performance of Medical Electrical Equipment
  
  
  • International Electrotechnical Commission (IEC) 62366 Application of usability engineering to medical devices
  
  
  • ISO 10993 Biological Evaluation of Medical Devices
  
  
  
  


• American Society for Quality-ASQ™ certification such as Certified Quality Engineer (CQE) or willingness to obtain


• Six Sigma experience and/or certification related to the design and manufacture of new products

For current employees, internal transfer restrictions may not apply. For more details, contact your local recruiter/HR team.

Work location: Remote or Hybrid in San Antonio, TX

Travel: May include up to 10% domestic

Relocation Assistance: May be 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

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.

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 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.

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