Michealle Havenhill
Head of Quality and Regulatory at Eurofins Transplant Diagnostics- Claim this Profile
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Bio
Scott Read
Having worked directly alongside Michealle on numerous biomedical projects I can say without reservation that she has a rare knack at organizing, deploying and wordsmithing meaningful Production/QA documentation systems that assures high quality products at the least cost. She is also unmatched in her ability to proactively identify production performance issues, determine root cause, and implement permanent correction solutions. She easily works well with any and all personnel at any level, is infectiously enthusiastic about her work, and is a key contributor to any company's bottom line and success. Scott Read
Scott Read
Having worked directly alongside Michealle on numerous biomedical projects I can say without reservation that she has a rare knack at organizing, deploying and wordsmithing meaningful Production/QA documentation systems that assures high quality products at the least cost. She is also unmatched in her ability to proactively identify production performance issues, determine root cause, and implement permanent correction solutions. She easily works well with any and all personnel at any level, is infectiously enthusiastic about her work, and is a key contributor to any company's bottom line and success. Scott Read
Scott Read
Having worked directly alongside Michealle on numerous biomedical projects I can say without reservation that she has a rare knack at organizing, deploying and wordsmithing meaningful Production/QA documentation systems that assures high quality products at the least cost. She is also unmatched in her ability to proactively identify production performance issues, determine root cause, and implement permanent correction solutions. She easily works well with any and all personnel at any level, is infectiously enthusiastic about her work, and is a key contributor to any company's bottom line and success. Scott Read
Scott Read
Having worked directly alongside Michealle on numerous biomedical projects I can say without reservation that she has a rare knack at organizing, deploying and wordsmithing meaningful Production/QA documentation systems that assures high quality products at the least cost. She is also unmatched in her ability to proactively identify production performance issues, determine root cause, and implement permanent correction solutions. She easily works well with any and all personnel at any level, is infectiously enthusiastic about her work, and is a key contributor to any company's bottom line and success. Scott Read
Experience
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Eurofins Transplant Diagnostics
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United States
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Hospitals and Health Care
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1 - 100 Employee
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Head of Quality and Regulatory
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Jan 2022 - Present
Lead the implementation, customization and ongoing operations of the Quality Management System (QMS). Ensures the QMS covers post-market surveillance for all products/services are monitored, tracked and completed to the satisfaction of the Customer. Ensures all SOPs are developed to ensure a solid foundation for operational quality and regulatory compliance with federal, state and accreditation bodies. Assist all departments to be inspection ready at all times and provides a basis for long-term continuous improvement. Show less
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Advanced Cell Diagnostics
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United States
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Biotechnology Research
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100 - 200 Employee
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Quality Assurance Manager
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Jun 2013 - Jan 2022
Implement 13485 Quality Management System and 21 CFR 820. Maintain and monitor NCPs, CAPAs, and Process Change Control. Manage Document Control Systems. Work with diverse groups within the company development, research, commercial, and manufacturing/operations. Perform internal and external audits. Host customer audits. Implement 13485 Quality Management System and 21 CFR 820. Maintain and monitor NCPs, CAPAs, and Process Change Control. Manage Document Control Systems. Work with diverse groups within the company development, research, commercial, and manufacturing/operations. Perform internal and external audits. Host customer audits.
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Knightsbridge Plastics, Inc
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Fremont, CA
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Quality Engineer
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Jul 2012 - May 2013
Ensure adherence to ISO 9001 and 13485, administer calibration, management representative and chairs management review meetings, reports on quality issues, problems and changes and continuous improvements. Manage the Internal/External auditing, parts measurement, First Article testing. Manages Customer complaints, RMA process investigation, complete CAPA requests. Ensure adherence to ISO 9001 and 13485, administer calibration, management representative and chairs management review meetings, reports on quality issues, problems and changes and continuous improvements. Manage the Internal/External auditing, parts measurement, First Article testing. Manages Customer complaints, RMA process investigation, complete CAPA requests.
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Thermionics Metal Processing, Inc.
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United States
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Semiconductor Manufacturing
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1 - 100 Employee
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Quality Manager
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2010 - 2011
Responsible for managing compliance to government regulations pertaining to the development and maintenance of the company’s quality management system (QMS). Manages the core QSM processes. Internal resource and subject matter expert on compliance issues. Makes recommendations on how to continually improve processes to comply with domestic regulations. Responsible for managing compliance to government regulations pertaining to the development and maintenance of the company’s quality management system (QMS). Manages the core QSM processes. Internal resource and subject matter expert on compliance issues. Makes recommendations on how to continually improve processes to comply with domestic regulations.
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HemoSense
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Medical Equipment Manufacturing
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1 - 100 Employee
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Director, Quality Control
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Dec 2001 - Jan 2007
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Document Control Manager
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2000 - 2001
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Sr Validation Transfer Chemist
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1997 - 2000
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Education
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San Jose State University
Bachelors, Zoology
Community
