Engr Quality

Solventum•Brookings, SD

3d•Onsite

About The Position

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 Quality Engineer in QMS / Facilities, 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: Leading Cross Functional Facilities Validations / Qualification activities: - Writing / Performing IQOQ documentation for new or remodeled production areas and labs -Participate in Project facility design development process Supporting requalification process’ for facility related areas – such as HEPA filter through third parties Supporting any facility maintenance or contamination control activities: review / approval / verification Drafting, reviewing, owning, and approving Facility and QMS Documents/Procedures to compliance requirements. Working closely with project managers, global sterility assurance, production and maintenance teams to perform troubleshooting and resolve facility design or damage issues. Lead Internal audits and audit teams Create and Complete Audit reports in ComplianceQuest Create and Manage CAPAs associated with Internal or External audits Host / Participate in external audits when necessary Act as QMS SME for Plant questions or concerns with reference to Regulatory Standards Develop and Maintain Pest Management through QMS compliance regulations Identifies, plans, recommends, and completes quality programs involving innovative applications and extensions of existing and new technologies of major importance to division business. Maintains extensive network of resources (laboratory, manufacturing, engineering, sales and marketing) to facilitate completion of assignments. Independently performs project planning. Establishes project objectives and priorities. Maintains an awareness of quality improvement and product opportunities and is productive in evaluating ideas and making proposals. Documents results, observations and conclusions in approved electronic files and prepares reports to communicate results to appropriate personnel. May train, counsel, and guide technicians, technologists, operation personnel, and engineers. Functions as an effective team leader and promotes harmonious and efficient working relationships. The job also requires performing other duties as assigned. Percentages of time spent on job duties are estimates and may vary for each position

Requirements

Bachelor's degree in science, engineering, or manufacturing discipline
Seven (7) years of experience related to handling and knowledge of test equipment and/or Metrology in a private, public, government or military environment.
Five (5) or more years of experience in engineering, validations, quality, or other technical role.
Troubleshooting, Investigation, Remedial Action, and Analysis of Non-Conforming Facility related issues.
Knowledge or certification in medical device industry regulations such as ISO 13485, ISO 9001, MDSAP, ANVISA, FDA QSR (21 CFR Part 11), and EU MDR.

Nice To Haves

Validation experience / knowledge
Professional quality certifications, such as Certified Quality Auditor (CQA), Certified Medical Device Auditor (CMDA), Certified Quality Engineer (CQE), or any others through American Society for Quality (ASQ) is preferred.
Demonstrated project leadership abilities on highly technical and complex projects.

Responsibilities

Leading Cross Functional Facilities Validations / Qualification activities
Writing / Performing IQOQ documentation for new or remodeled production areas and labs
Participate in Project facility design development process
Supporting requalification process’ for facility related areas – such as HEPA filter through third parties
Supporting any facility maintenance or contamination control activities: review / approval / verification
Drafting, reviewing, owning, and approving Facility and QMS Documents/Procedures to compliance requirements.
Working closely with project managers, global sterility assurance, production and maintenance teams to perform troubleshooting and resolve facility design or damage issues.
Lead Internal audits and audit teams
Create and Complete Audit reports in ComplianceQuest
Create and Manage CAPAs associated with Internal or External audits
Host / Participate in external audits when necessary
Act as QMS SME for Plant questions or concerns with reference to Regulatory Standards
Develop and Maintain Pest Management through QMS compliance regulations
Identifies, plans, recommends, and completes quality programs involving innovative applications and extensions of existing and new technologies of major importance to division business.
Maintains extensive network of resources (laboratory, manufacturing, engineering, sales and marketing) to facilitate completion of assignments.
Independently performs project planning. Establishes project objectives and priorities.
Maintains an awareness of quality improvement and product opportunities and is productive in evaluating ideas and making proposals.
Documents results, observations and conclusions in approved electronic files and prepares reports to communicate results to appropriate personnel.
May train, counsel, and guide technicians, technologists, operation personnel, and engineers.
Functions as an effective team leader and promotes harmonious and efficient working relationships.
Performing other duties as assigned.