Jean M. MacLeod

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Senior Quality Consultant

Jean has more than 20 years of management experience in the high-tech and medical device industries.  She has 14 years of experience in an engineering, supervisory and software quality assurance capacity.  Jean also has 15 years of experience in medical device quality organizations with Class II and III devices and is well versed in FDA and ISO regulations.  She has an extensive background in program management including account management.

 

EXPERIENCE…
  • Managed investigation of complaints from users as well complaint investigation processes performed by suppliers/contract manufacturers where she managed personnel of 28.  Significantly reduced the number of backlogged complaints as a result. Created and designed plans and strategies to achieve quality and compliance goals with regards to complaint handling and investigations.  Represented the complaint investigations during FDA, ISO and other regulatory body inspections.
  • Responsible for medical event reporting.  Reviewed and investigated customer complaints.  Managed the Medical Event Group, Complaint Evaluation & Closure Group and the Complaint Investigation Group on a national and international level.
  • Lead the divisional quality systems function which included CAPA, design control, document control, training and management reviews.  Lead the alignment of all processes and procedures for the design control and document control functions.
  • Developed and maintained processes for commercial distribution of ADC products and review of marketing materials. Participated in quality review board for CAPA system.  Participated in external inspections/audits.
  • Managed software validation group.  As part of the quality organization, supported all R&D groups with on-time delivery of our test-plans, protocols, test execution and reports.
  • Managed software verification, validation group and design process group.  Led the integration of the design control processes and procedures.
  • Experienced in program management including developing, maintaining, and driving overall schedule for projects.
  • Improved software development and validation processes.  Guided team through the development of and implementation of a software platform strategy.
  • Lead quality initiatives that included the introduction of a software inspection process.  Responsible for TQC.
  • Established policy and procedures for working with development groups.  Designed and developed software tools to automate the testing of graphics products.

 

POSITIONS HELD…
  • Senior Quality Consultant – BioTeknica, Inc.
  • Divisional Director, Quality Systems – Abbott Point of Care
  • Senior Manager Commercial QA; Director, Complaint Handling – Abbott Diabetes Care
  • Manager, Complaints Investigations & Supplier Complaint Handling – Abbott Diabetes Care
  • Manager, Product Software QA – Abbott Diabetes Care
  • Manager, Software Verification & Validation and Design Control – Abbott Laboratories/MediSense Division
  • Director of Program Management – Kana Software
  • Account Manager & Capability System Leader – Hewlett Packard Co.
  • Senior Software Quality Engineer – Hewlett Packard Co.
  • Software Quality Engineer – Apollo Computer Co.
EDUCATION…
  • B.A., Education, Sociology – Emmanuel College
CERTIFICATIONS…
  • Lean Six Sigma – Green Belt