Hi, I’m
Michael Rashidian
San Jose,CA
Summary
Dedicated Quality Director with 18+ years of exceptional leadership and extensive medical device industry experience. Strong analytical abilities and strategic planning skills to develop effective solutions to address production issues, improve operational efficiency and reduce overall waste costs through metrics. Excellent communication skills to collaborate with internal managers, QC team members and maintain strong customer relationships. Self-starter with a high level of discipline and motivation
Overview
14
years of professional experience
12
Certification
Work History
MOS Plastic Inc.
Quality Director
01.2020 - Current
Job overview
- Led the development and implementation of an ISO 13485:2016 and FDA 21 CFR Part 820-compliant Quality Management System, building it from the ground up for a brand-new manufacturing facility focused on producing finished medical devices
- Guided a global cross-functional team through the entire QMS lifecycle, ensuring alignment with international quality standards
- Successfully guided the team through audits, obtaining ISO 13485:2016 certification and FDA compliance, while optimizing processes for the efficient production of high-quality finished medical devices
- Reduced 73% of customer returns value by identifying the major source in the system, yield improvement and communicate effective solution with customer
- Responsible for managing team to perform Process Validation activities including but not limited to FAI, IQ, OQ, PQ and capability analysis (Cpk, Ppk)
- Oversee laboratory workflow and established priorities related to quality groups, ensuring compliance to regulatory standards (ISO 13485, FDA 21 CFR), productivity goals and deliverables
- Decreased 14% of quality cost by improving employees’ awareness, standardizing systems/procedures and implementing different measures and controls in the processes
- As Management Representative, responsible for arranging and undertaking internal audit and management review regularly to ensure the effectiveness of Quality Management System (QMS)
- Develop and maintain the Supplier Management System and managed over 150 suppliers, improves production efficiency and company profitability by ensuring suppliers’ compliance of quality agreement and processes
- Focal point for major customers for quality related aspects such as projects, issues, agreements
- Develop and implement QMS from scratch and drive the international sites to obtain ISO 13485 certification
- Conduct monthly continuous improvement meeting to initiate and undertake incremental improvements to processes
- Initiate and lead investigations for Non-Conforming and Out of specification material through root cause analysis, NCR and CAPA processes
- Facilitate and lead audits of critical suppliers to identify and resolve nonconformance issues
- Handle all customer and regulatory audits, managed corrective actions and reported results to regulators, customers, and company management
- Extensive experience in developing, implementing, training, maintaining and managing all aspects of Quality Management System, especially process improvement and product inspection
- Maintain highly successful working relationship with Production and Engineering departments to produce high quality products.
MOS Plastic Inc.
Quality Manager
01.2016 - 01.2020
Job overview
- Responsible for managing team to perform Process Validation activities including but not limited to FAI, IQ, OQ, PQ and capability analysis (Cpk, Ppk)
- Oversee laboratory workflow and established priorities related to quality groups, ensuring compliance to regulatory standards (ISO 13485, FDA 21 CFR), productivity goals and deliverables
- Decreased 14% of quality cost by improving employees’ awareness, standardizing systems/procedures and implementing different measures and controls in the processes
- As Management Representative, responsible for arranging and undertaking internal audit and management review regularly to ensure the effectiveness of Quality Management System (QMS)
- Develop and maintain the Supplier Management System and managed over 150 suppliers, improves production efficiency and company profitability by ensuring suppliers’ compliance of quality agreement and processes
- Focal point for major customers for quality related aspects such as projects, issues, agreements
- Develop and implement QMS from scratch and drive the international sites to obtain ISO 13485 certification
- Conduct monthly continuous improvement meeting to initiate and undertake incremental improvements to processes
- Initiate and lead investigations for Non-Conforming and Out of specification material through root cause analysis, NCR and CAPA processes
- Facilitate and lead audits of critical suppliers to identify and resolve nonconformance issues
- Handle all customer and regulatory audits, managed corrective actions and reported results to regulators, customers, and company management
- Extensive experience in developing, implementing, training, maintaining and managing all aspects of Quality Management System, especially process improvement and product inspection
- Maintain highly successful working relationship with Production and Engineering departments to produce high quality products.
NITI Tube
Quality Manager
01.2015 - 01.2016
Job overview
- Established, managed and maintained precise QC standards and participated in audits to ensure compliance to GMPs and ISO9001
- Improve quality performance by creating, developing and programming Coordinate Measurement Machine (CMM) and other measurement instruments for necessary incoming, in-process and final inspections
- Review, develop, refine, and validate QC inspection procedures
- Instructed and trained QA personnel to develop Quality Plan and production requirements to ensure necessities of quality are address and resolved
- Provide validation support by supervising validation performances and quality of products, including but not limited to IQ, OQ, PQ and Control Plans
- Managed day-to-day operations and supervised inspection team
- Maintained accurate records of all tests performed daily
- Collaborated with sales, production, and shipping departments to release on time final products
- Arranged schedule to keep up-to-date calibration of lab equipment around production.
MOS Plastic Inc.
Quality Control Supervisor
01.2012 - 01.2015
Job overview
- Plan and coordinate quality engineering tasks
- Assure evaluation of new product performances and compliance to regulatory requirements prior manufacturing
- Improve quality performance by creating, developing and programming Coordinate Measurement Machine (CMM) and other measurement instruments for necessary incoming, in-process and final inspections
- Implement ISO 9001 and 13485 Complaint Quality by performing internal annual audits and following up process, procedures and GMP standards
- Ensure good documentation practices by creating computer applications for efficient Q.A
- And document control monitoring
- Prepare and provide reports to superior management team
- Review, develop, refine, and validate QC inspection procedures
- Member of internal audit team for auditing company departments
- Managed NCR (Non-Conformance Report) process and escalation of Quality issues with production and engineering departments
- Assist compliant investigations, failure analysis of returned products
- Comply with and institute quality metrics to trend, recommend and implement corrective actions and appropriate follow-up when necessary.
Thermo Fisher Scientific
Quality Assurance
01.2010 - 01.2012
Job overview
- Monitor quality of material produced
- Operate controls to regulate temperature, speed and other processing conditions
- Change molds and adjust equipment for production line change
- Removes pattern and turns hand wheel to adjust guides, pressure bars, and table levels according to depth, position of cuts, and stock dimensions
- Troubleshoot, maintain and make minor repairs to equipment.
Education
Harvard Business School
Leading With Finance
09.2021
UCLA
Medical Device Engineering
06.2019
Global University
Master of Arts in Bible and Theology
01.2013
Skills
- Product Inspection
- Documentation Control
- Operational Excellence
- Product Development
- Process Documentation
- Performance monitoring
- Complex Computation
- Test Result Interpretation
- Specification Review
- Lean Manufacturing Methodologies
- Employee Training
- Team Collaboration
- Raw Material Inspection
- Staff Supervision
- Operational budget forecasting
- Defect Identification
- Goal Setting
- Organizational Skills
- Adaptability and Flexibility
- Critical Thinking
- Specification Development
- Continuous Improvement
- Problem-Solving
Certification
- Certified Medical Device Auditor (CMDA)
- Six Sigma Black Belt
- Lean Six Sigma Green Belt
- Total Quality Management (TQM)
- Documentation and Records
- CAPA System
- Medical Device Quality Management
- ISO 13485:2016 Lead Auditor
- ISO 13485:2016 Internal Auditor
- Managing a QMS
Timeline
Quality Director
MOS Plastic Inc.
01.2020 - Current
Quality Manager
MOS Plastic Inc.
01.2016 - 01.2020
Quality Manager
NITI Tube
01.2015 - 01.2016
Quality Control Supervisor
MOS Plastic Inc.
01.2012 - 01.2015
Quality Assurance
Thermo Fisher Scientific
01.2010 - 01.2012
Harvard Business School
Leading With Finance
UCLA
Medical Device Engineering
Global University
Master of Arts in Bible and Theology