DONNA KELLEY

**** ******** *****

Richmond, Texas 77406

P: 832-***-****

SUMMARY OF QUALIFICATIONS E: ac7d2t@r.postjobfree.com Accomplished Quality Assurance and Regulatory leader who leverages strong management, interpersonal skills, flexibility and teamwork to achieve quality objectives. Known for defining and implementing a shared vision of quality concepts that enhance the medical device industry. Recognized for achievements in:

• Development and implementation of a Quality System Manual for both FDA QSR and ISO 13485.

• An active member of Senior leadership driving strategic goals and quality objectives.

• Drive continuous improvement throughout the organization.

• Implement and maintain HSE programs for field, production and office employees.

• Implementation of Internal Quality Auditing Program for third party manufacturing practices.

• Implementation of a eQMS system (Master Control) from a paper based system

• Successfully achieved ISO 9001/ISO 14001 certifications from scratch.

• Preparation and submission of a FDA 510K for a PET/CT.

• Developing and implementing an effective CAPA program.

• Organization and control of documentation.

• Mentoring and coaching Quality Assurance teams in both auditing and training. PROFESSIONAL EXPERIENCE

OMNI Flow Computers, Inc. – Sugar Land TX 774**-****-**** Director of Quality Compliance

• Formulated, directed and implemented all quality-related systems and procedures, ensuring regulatory compliance throughout the organization

• Assisted in developing, establishing, validating, and troubleshooting analytical test methods and procedures for all products

• Conducted and hosted audits for vendors and relevant regulatory affairs, ensuring renewed licenses on all regulatory fronts

• Implemented an eQMS system (Master Control) from a complete paper based system. Continue to maintain accountabilities for SYSADMIN and corporate training of staff on the Master Control system.

• Transition the organization from ISO 9001:2008 to ISO 9001:2015

• Maintain current certifications for both safety and metrological approvals globally.

• Performed internal audits to monitor compliance to standards, policies, procedures and timelines.

• Facilitated during audits by third party auditors and Notified Bodies.

• Developed metrics and generated reports for supplier evaluation.

• Documented and submitted requirements for all product lines to Notified Bodies for CE marking application.

• Ensured all product documentations are in compliance to API, ISO, IEC and EU regulations.

DONNA KELLEY

1323 Woodfair Drive

Richmond, Texas 77406

P: 832-***-****

• Compiled and maintained Technical E: dkelley1973@Files (DHF) gmail.for com all product lines.

• Ensured that all products for international shipments comply with the standards and are supported by appropriate documents.

• Attend API Spring and Fall meetings and participate in working groups under API Standards Committees

• Participate in strategic goal planning and drive quality metrics to ensure achievement of results.

• Maintain and manage General Liability and Worker’s Compensation policies meet contract requirements for Field Service and product commissioning.

• Human Resources liaison with PEO for employee benefits

• Drive annual performance review for entire organization

• Drive all training activities for HSE, Corporate compliance. PCS-CTS – Houston, TX 770**-****-****

Internal Quality Auditor-Dell Computers

• Conduct internal quality audit throughout the repair facility.

• Conduct Process, QSM and ISO 9001 quality audits monthly in all departments.

• Issue CAPA to appropriate management for resolution.

• Chair CAPA implementation meetings as needed with Engineering and Production.

• Conduct and validate effectiveness the preventative checks action. on all CAPA’s closed in the previous month to verify

• Escalate unresolved or unanswered CAPA to Executive management as needed.

• Maintain the particle count in Class 100 and Class 1000 Cleanroom environments.

• Maintain down’ if any quality ‘Major’ requirements nonconformance. all production and cleanroom operations and ‘shut HEATH CONSULTANTS INC - Houston, TX 2006-2010

Documentation and Quality Manager

• Maintained and managed all controlled documents with Engineering and Production.

• Define and implemented a full Quality Manual.

• Managed the ECO process (Engineering Change Order). Held weekly implementation meetings involving procurement, production and engineering.

• Handle all new part number set-up and CPS (commercial part specifications)

• • Managed Managed all all incoming PCB Assembly inspection, Boom’s non-and conformance notified vendors and disposition. of changes in revisions.

• Handled all UL, CSA and MET on-site inspections as management representative.

• Created and maintained all new certification project for UL, MET and CSA.

• Using cost roll-DataWorks ups. ERP system managed all parts, BOM’s and BOO’s to effective run

• Conduct and supervise internal audits throughout the PBU (Products Business Unit). DONNA KELLEY

1323 Woodfair Drive

Richmond, Texas 77406

P: 832-***-****

POSITRON CORPORATION - Houston, E: dkelley1973@TX 1998-gmail.2006 com Manager of Quality Assurance and Regulatory Affairs & Marketing

• Developed and implemented a new Quality System Manual.

• Drive Regulatory Compliance for EU, FDA and ISO 13485 standards.

• Acting Management Representative for all Regulatory agencies.

• Handle PMA and 510K submittals.

• Radiation Safety Officer.

• Implemented the service department preventative maintenance and service/repair complaint handling process.

• Conduct trend and trigger analysis for Level 1, Level 2 and MDR complaints.

• Prepare and lead quarterly management review meetings.

• Maintained and review the CAPA program, conduct failure/CAR investigations on an as needed basis.

• Assign and schedule internal quality audits of all departments including service, materials, manufacturing and documentation services.

• Prepare software release documentation through a committee of software engineers.

• Prepare and maintain system DHR and service records.

• Write company responses to any 483 observations and/or warning letter findings.

• Attend, plan and promote/sell our PET scanners at all relevant medical shows such as American College of Cardiology, Academy of Molecular Imaging, American Heart Association, Radiological American Society of Society North America. of Nuclear Cardiology, Society of Nuclear Medicine and PROFESSIONAL AFFILIATIONS

• American Society of Quality (ASQ)

• Regulatory Affairs Professionals Society (RAPS)

EDUCATION AND CERTIFICATIONS

• BS Business Administration – University of Houston

• BS Engineering Management

• Master Control Training for Documents, Training, SYSADMIN, Process and Audit

• Birkman Method Certified

• Root Cause Analysis for CAPA - 36 hours credit

• Quality System Regulation Training - 40 hours credit

• ISO 13485 - 40 hours credit

• ISO 9001 - 120 hours credit

• 510K Submissions and CE Mark – 24 hours credit

• Risk Management Assessment – 36 hours credit

• Software Validation and Verification – 32 hours credit

• Design Controls – 40 hours credit

• Certified Regulatory Professional (RAPS)

• Certified Quality Auditor (ASQ)

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