Cheryl Fisher - Senior Consultant, Quality Assurance & Regulatory

In her role with Emergo, Cheryl is responsible for implementing and auditing FDA QSR and ISO 13485 compliant quality systems for medical device and IVD companies. She has extensive experience designing robust quality management systems that withstand regulatory inspections and regularly performs employee training on CE Marking, ISO 13485, FDA GMP and internal auditing.

Prior to joining Emergo, Cheryl spent several years with Boston Scientific/Guidant. In this capacity, she performed many ISO 13485 and FDA GMP audits, collaborated with auditees to develop corrective actions, communicated audit results to senior management and trained personnel on device regulations. Cheryl has also worked as a contract auditor for TUV Rheinland, giving her a unique perspective on how device companies should maintain compliance with regulations and standards.

EXPERIENCE:

Senior Regulatory Compliance Auditor and Business Analyst, Boston Scientific/Guidant (2004-2007)

• Developed audit schedules, performed audits to FDA and ISO regulations and standards, and communicated audit results to management and auditees per audit reports.
  
• Collaborated with auditees and management within the organization to develop full-bodied corrective actions that make sense for the business and customers.
  
• Worked within the CAPA system to ensure corrective actions were effective.
• Primary driver of 13485:2003 compliance initiative within Guidant, Cardiac Surgery, attained KEMA certification to ISO13485-2003 in late 2005.
• Business process development and improvement related to developing a fully compliant and highly efficient Product Development Process.
• Managed projects from a pipeline perspective and helped project managers that encounter system bottlenecks and resource shortfalls, this helps to ensure various projects stay on course from a financial and time-to-market perspective.
  
• Educated and trained personnel on the IPACE business model and Federal Regulations as they pertain to medical device manufacturers.

Independent Consultant, (1999-2004)

• Performed Quality Consulting, Technical Writing and Auditing Services for multiple clients including:
• LifeScan: Recruited to assist LifeScan in rebuilding its Quality System after FDA action. Served on the Materials Management Team, the Quality System Software Validation Team and within IQA developing documentation to better meet public and corporate needs.
  
• TUV Rheinland: Contract Auditor utilized within the medical device group, to support lead auditors recommendation of various medical device firms certification to ISO 13485 (1996 and 2003).
• Adobe: Developed and proofed internal procedures to better align with ISO 9001.
• HemoSense: performed Internal Audit function on a consulting basis, FDA and ISO 13485-2003 Invitro diagnostic device, measuring blood coagulant.
• Performed similar services for several other small corporations.

Writer/Accountant, Redcreek Communciations Technical (1998-1999)

• Performed Accounting, General Ledger, Accounts Payable and Payroll. Occasionally, did special projects for hardware and software engineers, in relation to technical communications in the form of user's manuals and code guides

Controller, Silicon Gear Corporation (1997-1998)

• Primary financial contact between IRS and State tax authorities, performed general accounting functions, developed the monthly and annual financial reports (BS) (P&L), had one direct report who processed AP.

Manager, StellarTech (1992-1997)

• Performed several functions as is customary for a small company. Two direct reports an Administrative Assistant and an AP Clerk.
  
• Primary corporate responsibility for all accounting functions, all purchasing functions, all Human Resource functions, Facility Safety, Hazardous Material disposal, and was the Contract Review Officer.
• One of four lead personnel utilized in attaining initial ISO certification for this medical device company.
• Managed the selection, procurement and installation of a corporate network and MRP system that increased efficiency of the operations department.
• Successfully negotiated terms with over 200 vendors, lowering raw material costs for RF generators developed and manufactured by an average of 35%.
• Successfully negotiated arrangements with large medical device organizations, which had acquired our original customer, to continue using Stellartech as the manufacturer of choice for their generators.
• Built and maintained an excellent corporate reputation and rating with Dun and Bradstreet that encouraged both potential customers to do business with the organization and vendors to offer preferred terms.

AREAS OF EXPERTISE:

Medical Devices:

• IVDs
• Durable devices
• Disposables
  

QA & RA:

• Quality system implementation - FDA GMP and ISO 13485
• Design Control
• Internal auditing
• CAPA management
• Post market surveillance
  

CERTIFICATIONS:

• RAB/QSA Principal QMS Auditor
• Certificate Technical Communications

EDUCATION:

• Bachelor of Arts in Liberal Studies, San Jose State University, California

HOME BASE:

• California, USA