Joshua Mello
Quality Engineering Manager @Integra LifeSciences
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WORK HISTORY
Quality Engineering Manager @Integra LifeSciences
Mansfield, MA, US
Responsible for all aspects of quality for 400 internally manufactured and 25k externally manufactured finished goods.•Lead, mentor, and coach a high-performance team of eight (8) production quality engineers responsible for process and equipment validations, test method validations, deviations, non-conformance and CAPA investigations, product hold management, manufacturing change support, test method validations, and operator certification.•Management of key Quality Management System elements including Control of Nonconforming Products, Deviations, and Change Control Projects. •Provided mentorship and guidance in the proper and effective use of quality tools and systems.•Developed and executed strategies to enhance the efficiency and effectiveness of the Quality Management System (QMS), ensuring compliance with industry standards through robust and easy-to-follow standard work.•Drove company quality standards, supported internal and external audits, and applied feedback to correct deficiencies.•Developed and implemented an Operator Certification Program, ensuring a highly skilled and qualified workforce.•Performed root cause analyses and implemented corrective actions for critical operational problems.•Managed the Complaint Evaluation Lab, ensuring robust failure analysis and feedback on customer-returned products.•Managed the production-based EU MDR remediation activities, ensuring alignment with regulatory requirements. •Analyzed processes and identified optimization opportunities for continual quality improvement. Increased throughput and reduced variation and ergonomic risk as part of a cross-functional improvement team that automated a labor-intensive manual deburring operation.•Actively improved employee relations by soliciting feedback for top management as the Mansfield site\'s Employee Engagement Ambassador
EDUCATION
Diman Regional Technical Institute
Diploma, Precision Machining
Bristol Community College
Engineering Science Transfer Program
SKILLS
ABOUT JOSHUA MELLO
We are here to have fun, to learn, and to make a difference.” - W. Edwards DemingExperienced Quality professional with a demonstrated history of working in the medical manufacturing industry. Skilled in ISO 13485, ISO 9001 FDA CFR 820, Management, Continuous Improvement, and Business Process Improvement.I believe that my prior success has stemmed from the following key beliefs:•Eagerly approach new opportunities to learn as continuous self-improvement is essential for growth.•Decisions must be weighted by risk first and then by the amount of value added.•The best way to collect data is to go to the source and then utilize a hands-on approach.•Never be afraid to ask questions about things you do not fully understand.•Team building is essential and will help facilitate the effectiveness of future collaborations.•Fun is a choice. Regardless of the scope of the task, it can always be resolved in a positive manner.
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