SUMMARY:

ASQ certified Software Quality Assurance professional with over 8 years’ experience in the FDA regulated medical device industry with extensive software validation and equipment qualification skills. Experienced with IQOQPQ Validation Planning, Requirements Analyses, Software Testing, Validation Reporting and documentation of all SDLC phases. Thorough and efficient quality assurance reviews of technical documentation ensuring procedural and regulation compliance. Personable team player with cross functional collaboration effectiveness to complete validations efficiently and in compliance. Detail oriented in detection and resolution of compliance issues. Experience with CAPA and Nonconformance process. Experienced with Non Product Software Remediation projects.

SKILLS SUMMARY:

Software Quality Assurance DOORS (IBM) (Requirements Management)

FDA Regulation 21 CFR Part 820 Software Development Life Cycle (SDLC)

TestTrack (Seapine Software) Non Product Software Remediation

Windchill and Documentum SQL Language

Facilities/Utilities Qualification 21 CFR Part 11 Electronic Records

Minitab Discrepancy Resolution

Good Documentation Practices Spreadsheet Validation

PROFESSIONAL EXPERIENCE:

Confidential, Bloomington, MN

Software Test Engineer

Responsibilities:

• Supported Product Development to provide software testing of refrigeration temperature control and HMI software used in transport refrigeration systems.
• Performed final testing of Service Tool software.
• Performed manual software testing using simulators.
• Software validation including specification review, test preparation, test execution, results analysis, and defect reporting.
• Performed Regression Testing on software products.
• Worked with IBM Rational Doors for requirements management and TestTrack Pro for test and defect reporting.

Confidential, Fridley, MN

Software Validation Engineer

Responsibilities:

• Provided Software Validation support to Non Product Software Remediation Project.
• Responsible for validation of: Receiving Inspection systems, IT systems, spreadsheets and custom software.
• Provided quality assurance review of documents.
• Provided gap analyses. Authored validation plans, requirements, test scripts, trace analyses and validation reports.
• Test Case execution. Provided test execution to contractors and system owners.
• Responsible for leading team for validation of IBM Rational ClearQuest via multiple environments.

Confidential, Maple Grove, MN

Software Quality Assurance Engineer

Responsibilities:

• Provided primary SQA validation support to multiple departments such as Facilities, Operations Analytical Labs, Complaints Lab, Design Assurance, R&D Labs, Quality Systems and Manufacturing.
• Software Quality Assurance review of validation deliverables to ensure compliance to SOPs based on FDA 21CFR 820.
• Led and supported efforts to resolve non - conforming events (NCEs) and CAPA projects.
• Experience with defect management.
• Responsible for Validation Plans, Intended Use Base Risk, Hazard Analysis, Business and User Requirements, Design Review, Testing and Validation/Verification Reports using Waterfall Methodology.
• Lead Software/Quality Assurance Engineer supporting Facilities department for over 7 years.
• Recipient of Quality Ambassador for exceptional customer support
• Experience as a CAPA team member and trained on eCAPA process
• Initiated and developed software change SOP for Software Change Control (Value Improvement Project)
• Responsible for updating Standard Operating Procedures for IQOQPQ for laboratory systems.

Confidential, Oak Park Heights, MN

Project Engineering Supervisor

Responsibilities:

• Managed maintenance and construction contracts for HVAC, janitorial, landscaping, roofing and parking lots.
• Developed Capital Expenditure Requests and presented them to Capital Management Committee.
• Managed installation and inspection of roofing and parking lot projects in excess of $500,000.

Confidential, Minneapolis, MN

BAS Project Engineer

Responsibilities:

• Provided layout and design of building automation HVAC temperature control systems and equipment for al, commercial and industrial facilities.
• Preparation of temperature controls submittals and as built drawings using AutoCAD.
• Supported project managers with HVAC controls installation projects.

Confidential, Brooklyn Park, MN

Research & Development Lab Technician

Responsibilities:

• Performed research and development testing of surgical ablation products.
• Tested and evaluated prototype electrodes with bovine and swine cardiac tissue with use of RF generator.

Confidential, Minneapolis, MN

Technical Resource Manager/Field Service Team Lead

Responsibilities:

• Provided onsite management of several interdivisional facility contracts.
• Provided technical solutions, service and installation support for mechanical systems, energy conservation projects, preventative maintenance, computerized maintenance management systems, database queries and reduction in downtime of production equipment.
• Managed subcontractors for diesel generators, fire alarms, building automation, security and HVAC systems.
• Equipment and parts purchasing.
• Annually exceeded contract profit margin goals
• Provided engineering and building automation support in successful Electric Curtailment Program.
• Instrumental in acquiring long sought after contract, via exceptional customer service.