Senior Engr Quality(Solventum)
Confirmed live in the last 24 hours
University Health
Compensation
$106,000 - $145,750
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 Senior Quality 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:
- Lead the development of process risk management per ISO14971 for assigned projects.
- Provide quality engineering services for new and existing medical device products and feedback to product development and manufacturing.
- Lead failure investigations and problem resolution.
- Participates in and leads assigned project teams/tasks for the development and support of new and sustaining products and processes by providing quality engineering services to assigned projects with accountability for development, execution, and reporting of assigned activities for test method validation, design and process verification and validation, etc.
- Reviews and approves updates to quality system documents, quality system documentation, and labeling for new and existing products
- Mentors lower-level engineers in technical and professional development
- Reviews drawings to evaluate quality requirements including correct application of geometric dimensioning and tolerancing, proper use of engineering, process and material specifications, and identification of key characteristics for inspection plans and methods.
- Facilitates audit functions to support audits by governmental competent authorities (e.g., US Food and Drug Administration (FDA) inspections), Notified Body audits, and internal/corporate audits; May participate in audits as a Technical subject matter expert.
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 in Engineering or Engineering Science and (3) years of experience as a Quality Engineer within a medical device organization in a private, public, government, or military environment
In addition to the above requirements, the following are also required:
1 year of experience working under FDA regulations and recognized quality standards, including ISO 14971
Additional qualifications that could help you succeed even further in this role include:
- Demonstrated experience conducting root cause investigations for medical device, biotechnology, and pharmaceutical products.
- Experience reviewing and approving process validation reports, as well as verification and validation activities.
- Proven ability to review and approve updates to Quality System documentation, Design History Files, and product labeling for new and existing products.
Work location: Hybrid Eligible (Job Duties allow for some remote work but require travel to San Antonio, TX at least [2] days per week)
Travel: 5% [domestic and/or 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.
Applicable to US Applicants Only:The expected compensation range for this position is $106,000 - $145,750, 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-RewardsResponsibilities 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.
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