MARCUS CAYEMITTE
Senior Quality Scientist
Miami,FL
Summary
Scientist with 10+ years of experience in Quality Systems and Operations Management in the medical device and cosmetic industries. Proven ability to manage cross-functional workstreams and competing priorities with speed and agility. Critical thinker well versed in Post Market Surveillance as well as continuous process and product improvement. Leads a team of Quality Engineers in root cause analysis and manage that have reduced the amount of incoming customer complaints and that have reduced the cost incurred through customer instrument service and repair visits Regulation experience includes ISO 13485, CFR 21 820, and 40 CFR 152.3.
Overview
14
14
years of professional experience
Work History
Senior Quality Scientist
Beckman Coulter
05.2015 - Current
- Company Overview: Part of a global organization with Complaint Handling Units located worldwide
- Lead analyst in the Complaint Handling Unit; Responsible for the investigation of customer complaint service records, and the reporting of non-conformances and adverse events for multiple product lines including Hematology, Life Science, Urinalysis, and Reagents in accordance with regulation trends; Owner of daily management report tracking team performance objectives
- Manage multiple Post Market Surveillance projects; Identify critical product issues, escalate issues through the quality system and lead cross functional team in the preparation, submittal and execution of Root Cause analysis, Field Action, Corrective and Preventative Action (CAPA) and Supplier Corrective Action Reports (SCAR)
- Supervise FDA response team; Train associates in quality system and process to address FDA audit findings and remediation actions
- Owner of daily management report tracking team performance objectives; Reports to Quality Director providing monthly quality metrics and counter measures for failed metrics
- Review and update quality procedures and work instructions leading to improvement in the quality and turn around time of complaint investigations, improving complaint efficiency, shortening complaint investigations turnaround time and reducing complaint investigation non conformances
- Communicate, work cross-functionally and consult frequently with Manufacturing, Operations, Engineering, Service/Support, Sales, Research and Development, Quality Regulatory and Marketing
- Design and implement global trending; used to statistically analyze complaint data for product improvement and determination of CAPA/SCAR opportunities
- Support audit preparation; Oversees pre work and readiness for external and internal audits of the Quality Systems and Processes
- Part of a global organization with Complaint Handling Units located worldwide
- Facilitated training sessions for team members on quality management principles and best practices, enhancing overall competency levels within the department.
- Implemented process improvements based on Lean Six Sigma methodologies, resulting in reduced waste and increased efficiency.
- Developed comprehensive quality assurance documentation to streamline audit process, significantly reducing preparation time.
- Collaborated with R&D to integrate quality considerations into early design stages, enhancing product durability and functionality.
- Analyzed and interpreted data to identify trends and recommend improvements.
- Improved customer satisfaction levels with timely resolution of non-conformance issues and effective corrective actions.
- Contributed to root cause analysis to determine core reason for failures and errors.
Environmental Specialist
Arkema
01.2014 - 01.2015
- Product Manager for Paladin, a pre-soil fumigant; Coordinated phasing out an existing fumigant while facilitating the launch of Paladin into the South Florida tomato farmer industry
- Created training and standard operating procedures for 12 local farms for the use and handling of Paladin fumigant
- Conducted weekly Volatile Organic Compound testing and monitoring across multiple sites to monitor the surrounding air quality in compliance with EPA regulations
Quality Technician
B&R Products
01.2011 - 01.2014
- Created quality control program for a cosmetic products manufacturing facility in accordance with industry standards
- Owner of retain inspection process, to test and inspect samples in response to customer complaints
- Implemented quality processes and standard workflows for testing and releasing raw materials and finished goods
- Trained colleagues on compliant and proper documentation practices
Education
Bachelor of Science - Chemistry
Florida International University
Skills
Results analysis
Data analytics
Quantitative skills
Critical thinking
Problem-solving abilities
Teamwork and collaboration
Accomplishments
- Participated in 4E Energy Management Kaizen to reduce the electricity usage and GHG emissions at the Beckman Coulter Kendall and Hialeah facilities.
- Developed Miami LS DM to manage complaint distribution and team metrics.
- Selected by Quality VP to train on the manufacturing of Immunoassy reagent manufacturing at the Chaska, Minnesota site and support the review and approval of Non Conformance submissions.
Timeline
Senior Quality Scientist
Beckman Coulter
05.2015 - Current
Environmental Specialist
Arkema
01.2014 - 01.2015
Quality Technician
B&R Products
01.2011 - 01.2014
Bachelor of Science - Chemistry
Florida International University
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