Senior Engr Quality (New Health Care Company)

SOLVENTUM • San Antonio, TX

1d • Hybrid

About The Position

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:

Requirements

• Bachelor’s Degree or higher in Engineering Science from an accredited institution completed and verified prior to start and three (3) years of experience as a Quality Engineer for a medical device company conducting root cause investigations on medical device , bio-technology, and pharma products, reviewing and approving process validation reports, verification and validation, reviewing and approving updates to quality system or design history documents and labelling for new and existing products based on United States Food and Drug Administration (FDA) regulations and recognized quality standards, including ISO14971 in a private, public, government or military environment
• Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Responsibilities

• 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.

Benefits

• 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.
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level