Samantha Rondeau
Pittsburgh,PA
Overview
6
6
years of professional experience
Work History
Manufacturing Engineer II – Plasma Division
Haemonetics Corporation
Pittsburgh
12.2023 - Current
- Manage all aspects of plasma nonconformances including root cause analyses (RCAs), immediate fixes and long term solutions, product sampling and dispositioning, proper documentation, and trend reports
- Drive machine, mold, and equipment changes based on nonconformances and line output
- Write and execute installation, operational, and process qualifications (IQs, OQs, and PQs)
- Generate and perform verifications and test method validations (TMVs)
- Initiate and implement corrective and preventative actions (CAPAs)
- Lead cross-functional Kaizen teams to improve manufacturing processes
- Standardizing the manufacturing instructions and practices for all molded parts at the site
- Re-structuring the process failure modes and effect analyses (pFMEAs) based on those updates
- Collaborate with production, quality, PM, R&D, regulatory, labeling, and clinical teams
- Trained 100+ employees on the electric device history (eDHR) system and its applications
Associate Quality Engineer – Repositioning & Offloading, Personal Care, and Skin Care Divisions
Medline Industries
Chicago
06.2021 - 11.2023
- Mentored a rotational quality engineer on quality standards and skill enhancements
- Led an interdisciplinary Kaizen group on fixing systemic complaint intake issues
- Piloted product design and development projects to enhance devices and build business
- Coordinated lab testing, analyzed acquired data, and communicated results
- Partook in internal audits and drove mock audits to uphold the quality system
- Evaluated, approved, and worked with manufacturers to promote growth
- Requested supplier corrective and preventative actions to compel change
- Conducted department-wide trainings on different topics such as complaints
- Investigated and resolved customer complaints and medical device reports
- Spearheaded an engagement team that planned fun employee events
Patient Attendant
Michigan Medicine
Ann Arbor
06.2020 - 08.2020
- Monitored high-risk patients to maintain their safety
Education
Bachelor of Science - Biomedical Engineering
University of Michigan
Ann Arbor05.2021
Some College (No Degree) - Traditional Healthcare Practices
University of Antananarivo
Madagascar08-2018
Skills
- Team leadership
- Cross-functional coordination
- Strong collaboration
- Effective communication
- Problem solving
- Analytical skills
- Continuous improvement
- Root cause analysis
- Failure modes and effects analysis
- Corrective action implementation
- Quality system management
- Manufacturing processes
- Process qualification
- Kaizen leadership
- Employee training
Volunteer Experience
Michigan Health Engineered for all Lives (M-HEAL) 09/17 - present: Currently mentor M-HEAL undergraduates on their academic and personal growth; Co-founder of Project MIA – conducted needs assessment in the Peruvian Amazon and led a cross-disciplinary undergraduate team to improve the menstrual experience for Peruvian women; Member of Project Alivio – traveled to Guatemala and introduced 4 low-fidelity prototypes that would reduce pressure ulcer incidences
Certifications And Awards
- ISO 13485:2016 Certified for Medical Device Quality Management Systems
- Received the 2023 Teamwork of the Year Award from the Medline Quality Group President
- Received an honorary pin from the University of San Carlos Dean during M-HEAL travel
Activities
- Pittsburgh Sports League Member – tennis, volleyball, kickball, pickleball, and flag football
- Family Cooking FaceTime Officer – guide weekly, virtual cooking sessions with family
Timeline
Manufacturing Engineer II – Plasma Division
Haemonetics Corporation
12.2023 - Current
Associate Quality Engineer – Repositioning & Offloading, Personal Care, and Skin Care Divisions
Medline Industries
06.2021 - 11.2023
Patient Attendant
Michigan Medicine
06.2020 - 08.2020
Bachelor of Science - Biomedical Engineering
University of Michigan
Some College (No Degree) - Traditional Healthcare Practices
University of Antananarivo