Project Manager, Systems Analyst, Data Analyst

Overview

Primary Function / Primary Goals / Objectives:
Coordinate Software QA activities in support of a new product launch or an upgrade to an existing product. Estimate, plan and review own and other's work product.

Document and maintain archives for all Software product related quality activities such as plans, schedules, meeting minutes, management reviews, and departmental reviews.

Prepare status reports and present to Quality Management.

Ensure that computerized systmes used in support of the Quality System are developed, validated and maintained in compliance with regulatory, divisional and corporate requirements.

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Strategic
  • Develop Software QA requirements and programs to meet strategic needs of the business.
  • Communicate software QA project status to development teams and Quality management.
  • Balance product cost, performance, software quality and time to market issues in order to meet ADC goals.
  • Coordinate activities between SWQA and operational and product development organizations from project initiation through launch.
• Tactical
  • Drive all Software QA activities associated with external development partner or internal development team.
  • Participate in regular project review meetings to coordinate and document the Software QA activities with associated departments contributing to a timely product launch, including QA/RA, Marketing, Operations, and R&D.
  • Generate and control various documentation as appropriate, such as Software QA plans, protocols, reports, resources assignments, etc.
  • Develop SWQA project costing estimates working with R&D, Operations, and Finance.
  • Provide input to the Quality process.
  • Manage Software QA costs on a project.
  • Assist SWQA team members in meeting their goals by providing coaching and mentoring as needed
  • Recruit, train and evaluate performance of personnel.
  • This position is responsible for team integration on a project for SWQA team performance, and for evaluation and reporting project status to Quality management.

Typically, the incumbent would have a minimum of a bachelor’s degree in a technical discipline. An advanced degree in either technical business field is desired. This educational background would prepare the individual for directing technical activities in a manner consistent with business drivers and both short and long term business strategies

Minimum Experience/Training

Required:

Knowledge of Program Management tools such as project scheduling, work breakdown structures, time and cost reporting, is desired.

Experience in both development and manufacturing of medical products for retail or hospital distribution is desired.

This position requires the ability to collect information from multiple sources, sort through, integrate, and resolve often conflicting requirements, and drive an organization through the varioussoftware QA issues to result in a successful and timely software product launch.

Project management with software development with increasing demonstrated responsibility and success. Experience leading and participating in technical cross-functional projects.

Strong problem-solving, communications and facilitation skills.

Prior experiences in medical device and/or in-vitro diagnostic industry required.

Expect candidate to proactively identify and resolve resource conflicts and set priorities of parallel projects.

Experience with both internally and externally developed life-science software products.

Demonstrated success from initial concept to final release (full software life cycle).

Knowledge of and experience with modern software testing best practices, methodologies, and techniques, particularly in testing medical devices. 10 years experience with firm knowledge of QSR/ISO/MDD/IVDD quality systems requirement, especially as they relate to software validation. In particular, has knowledge of design control requirements.

Knowledge of and experience with modern operating systems (Windows), Internet technologies, object-oriented languages (e.g. C++ and/or Java), software components and instrumentation.

Accountability / Scope:
This position is highly visible and accountable, responsible for directing, and reporting to Quality management, the Software Quality Assurance activities in the launch of product and non-product applications.

This position will provide leadership to project teams, integrating SWQA activities across all departments, with influence across departmental lines.

Will estimate, plan and prioritize resources for multiple projects to deliver quality designs on schedule. Failure to properly validate systems may result in recalls, product deficiencies and/or disruption to business.