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Quality Assurance Specialist
2 months ago
Solventum is a leading company in the healthcare industry, and we are seeking a highly skilled Quality Engineer to join our team. As a Quality Engineer, you will play a critical role in ensuring the quality of our products and processes.
Key Responsibilities:- Lead Corrective and Preventive Action (CAPA) projects to identify and resolve quality issues
- Represent the customer and drive a quality environment and mindset throughout the plant
- Interact globally with Solventum facilities for quality improvement or localization efforts
- Lead and oversee change management as it relates to design changes driven by quality improvement, source of supply changes, or cost reduction efforts
- Lead plant-level Supplier Quality program, including Supplier Corrective Action Requests, TQRDC, Supplier Audits, and Supplier Change notifications
- Lead continual improvement activities with Suppliers to ensure accurate specifications and acceptance criteria are defined and understood
- Bachelor's Degree or higher from an accredited institution, with a minimum of one year of experience in quality, technical, lab, engineering, manufacturing, and/or plant environments
- High School Diploma/GED and a Completed Technical Diploma from an accredited institution, with a minimum of four years of experience in quality, technical, lab, engineering, manufacturing, and/or plant environments
- High School Diploma/GED from an accredited institution, with a minimum of five years of experience in quality, technical, lab, engineering, manufacturing, and/or plant environments
- Degree in Material Science, Mechanical Engineering, or Chemical Engineering from an accredited institution
- Three years combined work experience in Quality Engineering, Product Engineering, Six Sigma, and/or Manufacturing environments
- Five years of medical device experience in a private, public, government, or military environment
- Familiarity with manufacturing processes
- Demonstrated experience conducting quality systems audits
- Statistical knowledge and practice with Gage Repeatability and Reproducibility (R&R) studies, Statistical Process Control (SPC), and Process Capability
- Strong customer focus and consultative skills, with a proven ability to develop solutions to difficult problems
- Excellent written, verbal, presentation, and interpersonal communication skills
- Strong analytical, decision-making, and problem-solving skills
On-site in Morden, MB
Travel:May include up to 10% domestic/international
Relocation Assistance:Not authorized
Must be legally authorized to work in country of employment without sponsorship for employment visa status