Document Control Medical Device
Resume:
SUSAN PIASECKI
• San Jose, CA ***** • 408-***-**** • **********@*******.*** • 408-***-**** (cell)
A successful, accomplished Document Control Manager, with excellent planning, organizational and inter-personal skills, seeks a new position.
SUMMARY OF QUALIFICATIONS
• Over 20 years of professional experience within the manufacturing Industry.
• Diverse professional with experience in management, documentation, corporate procedures and personnel issues.
• Proven ability to form strong relationships with and gain trust of colleagues and clients at all levels.
• Detail orientated multi-tasker with extensive analytical, organizational and management skills.
• Superior troubleshooting, problem solving and conflict resolution skills, with exceptional focus and follow through abilities.
• Popular, tactful team player who thrives within group environment.
EDUCATION
UCSC Extension Program
Key Subjects: Medical/Clinical Terminology, Effective Employee Relations, Managing the Staff Function, Clinical and Regulatory Affairs Program
PROFESSIONAL EXPERIENCE
PATHWORK DIAGNOSTICS, INC 2011- AUG 2012
Document Control Manager
• Responsible for all standard operating procedures and Clinical Protocols.
• Continued monitoring all DCO’s and FDA binders.
• New Employee Training to Electronic Software system.
• Technical lead to find and implement company’s Software Document Control Electronic System
• Created step by step instructions for company’s new Document Control Electronic Software System
• Worked to do the original software validation prior to launch, as well as amendments of changes done after Electronic Software launch.
• Responsible for all new employee training of company’s Document Control Electronic Software System
• Responsible for all Electronic Software Customizations and Validations of company’s Document Control Electronic Software System
PATHWORK DIAGNOSTICS, INC 2008- 2010
Sr. Document Control Specialist
• Responsible for establishing standard operating procedures, pursuing outstanding documents awaiting review or approval to drive documents to completion.
• Monitoring all DCO’s, Clinical Protocols and FDA binders.
• Assisting with document creation, document revision and annual review of documents.
• Verifying that documents follow correct document content and format requirements.
• Employee Training as new documents are implemented or updated.
• Maintaining Qualified Supplier’s list
• Responsible for updating training and signature approvers matrices
Susan Piasecki Page 2
SUNI MEDICAL IMAGING, INC., San Jose, CA 2003 – 2008
QA Supervisor / Sr. Document Control Specialist
• Responsible for developing, implementing and maintaining procedures to support all Quality Control and Document Control aspects of the organization, engineering drawings, ECNs, technical reports, forms, Part Numbers and Approved Supplier’s Lists.
• Maintaining vendor qualification program and quality control for all aspects of the manufacturing organization and interfacing with suppliers on quality issues.
• Conducting internal audits and other QA/QC functions as needed to ensure compliance with FDA, ISO 13485 Standards, MDD, and CMDR. Interfacing with Auditing Body and Notified Bodies (CE Mark) on scheduled Audits.
• Responsible for the Corrective and Preventative Actions process.
• Overseeing the RMA Process, Warranty Repair returns and statistics on Product Returns.
• Reporting directly to the Chief Operating Officer and conducting regular management review meetings to ensure the QMS System.
CATALYTICA ENERGY SYSTEMS, INC., Mountain View, CA 1998 – 2002
Document Control Specialist
• Developed implemented and maintained procedures to support the company's electronic document control system, encompassing forms and engineering drawings, process/product deviations, ECRs/ECNs, technical reports and approved supplier’s lists.
• Maintained document control between the Mountain View, CA and Gilbert, AZ sites.
• Directed vendor qualification programs, supplier survey reports and confidentiality agreements.
• Monitored internal/external audits to ensure compliance with ISO Standards, conducted employee training for ISO Certification and maintained employee training records.
• Organized Social Events, such as the Annual Summer Picnic, the Halloween Party, the Holiday Party and Monthly Payday Parties.
VERBATIM CORPORATION, Sunnyvale, CA 1977 – 1998
Documentation
• Generated new documentation, performed red line revision changes and ensured accessibility, and updated Master Documentation List.
• Handled product/process deviations, filed ECNs, and oversaw annual document review.
• Created BOMs, part numbers for raw materials, chemicals and finished Goods; set up databases and compiled data for engineering groups.
• Received Presidents Award 3 times during tenure with company.
Lead Auditor/Vendor Quality
• Ensured continuing compliance through internal/external audits.
• Oversaw and directed vendor qualification, quality problems, customer complaints, and shipping of samples to potential clients.
Scheduling Assistant
• Accurately compiled production floor totals on daily basis, and set production runs in accordance with forthcoming order levels.
• Maintained warehouse inventory levels, through monitoring raw materials received and incoming shipments.
Manufacturing Lead
• Held responsibility for quality of daily output and operator performance; implemented process modifications, updated departmental procedures and ensured appropriate training.
• Successfully met pack-out requirements, managed physical and fiscal inventory.
• Conducted employee training, purchased department materials and controlled Min-Max levels.
Susan Piasecki Page 3
COMPUTER SKILLS
Word, Excel, Access, PowerPoint, MS Outlook
TRAINING
ISO 9001 Lead Auditor Training
Medical Device Assessor Training
ISO 13485 Lead Auditor Training
Application of Risk Management to Medical Devices / ISO IEC 14971
Good Manufacturing Practices (GMP) for the Medical Device Industry
UL Product Realization Training
NetSuite
Documentum
Documentation Configuration Management
Master Control
AssurX / CATSWeb Electronic Document Control Software System
KEYWORDS
Document Control, ISO Auditor, AssurX /CATSWeb, Master Control, Documentum, ISO 13485 Training, Medical / Clinical Terminology, Medical Device Experience, FDA, ISO, MDD, GMP, CMDR, MS Word, Excel
References Available Upon Request
Contact this candidate