Engr Quality(Solventum)

SOLVENTUM•San Antonio, TX

2d•$71,200 - $97,900•Hybrid

About The Position

Solventum is a new healthcare company with a long legacy of creating breakthrough solutions for 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. People and their well-being 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.

Requirements

Bachelor’s Degree or higher in Engineering or Engineering Science
One year of experience as a Quality Engineer within a medical device organization in a private, public, government, or military environment
1 year of experience working under FDA regulations and recognized quality standards, including ISO 14971
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Nice To Haves

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.

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.
Corporate policies, procedures and security standards are complied with while performing assigned duties.