Senior Quality Engineer (Remote - United States)
Job Description
Job Description:
Senior Quality Engineer (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
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:
- Providing quality assurance engineering support for marketed medical device products including customer complaints, stability studies, test method validations, investigations, risk management, change management and continuous improvement.
- Leading investigations for nonconforming materials, complaints, and supplier issues.
- Assuring compliance to internal Standard Operating Procedures (SOP's) and external regulations. Leading Corrective and Preventive Action (CAPA), Risk Management including Post Market Surveillance product support, Risk Reviews, and Material Review Boards.
- Representing the customer, evaluating customer complaints and issues, samples and trends, and determining the necessary action plans.
- Interacting with other Solventum facilities and outside suppliers to ensure product quality and performance.
- Other duties as assigned
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 (completed and verified prior to start) AND three (3) years of combined product, quality, engineering, and/or laboratory experience in a private, public, government or military environment
OR - High School Diploma/GED AND seven (7) years of combined product, quality, engineering, and/or laboratory experience in a private, public, government or military environment
Additional qualifications that could help you succeed even further in this role include:
- Experience working in an FDA-regulated device, combination product, or pharmaceutical environment
- Experience supporting medical device product quality issue reviews, including design controls, requirements, and test method validation activities
- Experience leading initiatives or teams, including identifying improvement opportunities and driving change across cross-functional stakeholders
- Experience applying statistical and quality engineering tools, such as basic statistics, Gage R&R, Analysis of Variance (ANOVA), Failure Modes and Effects Analysis (FMEA), Statistical Process Control (SPC), process capability analysis, acceptance sampling, correlation and regression, and design of experiments (DOE)
- Experience influencing stakeholders and driving outcomes related to compliance, continuous improvement, product risk mitigation, or manufacturing process capability improvement
- Experience communicating technical or quality-related information, including providing concise, fact-based updates to leadership and cross-functional teams
- Experience applying problem-solving and continuous improvement approaches to prioritize work, manage competing demands, and deliver results
Work location: Remote in United States (preferred with ability to commute to Eagan, MN or a US manufacturing plant location as needed to support job responsibilities such as complaint sample analysis)
Travel: May include up to 10% domestic/international
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
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.
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.
Please note, Solventum does not expect candidates in this position to perform work in the unincorporated areas of Los Angeles County.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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