Manager, Software Quality Engineering PHT
THIS JOB HAS EXPIRED Department: Technical Operations
Reports to: Director, Project Quality & Performance Improvement
The Manager, Software Quality Engineering is a hands-on leadership role with responsibility in managing all Quality Assurance processes for handheld and web-based applications. In addition to the responsibilities listed below, this individual will:
Participate in initiatives to reduce cost, improve quality, and improve efficiency in existing processes or by implementing new processes.
Reach appropriate resolution in many varied situations without damaging internal or external relationships.
Think ?globally? by understanding and communicating vision and purpose beyond short-term goals and outside of the Department.
Successfully manage situations there is ambiguity such as unstructured activities, indirect accountability, and unclear mandates.
Proactively focus on business issues at hand and make decisions which optimize trade-offs among competing priorities.
Directly supervise the performance of the SQE team, providing leadership and solving technical challenges as necessary.
Oversee the performance of offshore testing vendor.
Assign tasks to the project development team of SQEs and monitor their efficiency.
Write, review and approve validation plans, traceability matrices, test scripts and validation reports in accordance with application development efforts and pertinent SOPs and Work Instructions.
Serve as a subject matter expert in cross-functional collaborations with other PHT departments and groups in the development of best practices and process improvements.
Recommend quality improvements or changes to development processes, procedures, and systems and software products to correct known or potential deficiencies.
Maintain and develop appropriate departmental SOP?s, Work Instructions, and templates.
Ensure that appropriate training is conducted for SOP?s, Work Instructions, and templates and that they are adhered to by SQEs.
Participate in the review of other relevant SOP?s, Work Instructions, and templates.
Prepare periodic reports for management as requested summarizing performance metrics.
Assure accurate and timely input by SQE personnel into the time reporting system and approve timesheets upon completion.
Attend project meetings and assess SQE effort for multiple projects running simultaneously.
Prepare and/or maintain position descriptions, competency models, and training materials for the SQE group.
Participate in audits by external parties as required by the Director of Quality Management and Compliance; respond to audit findings and observations as necessary.
Conduct internal audits to ensure compliance with Quality Management System and FDA regulations.
Assign and coordinate tasks to an offshore team of SQEs and monitor their efficiency.
Oversee requirements and design specification reviews.
Oversee test script development by SQEs and ensure their quality, accuracy and completeness.
Hire, train and manage SQE personnel.
Conduct performance appraisals.
Create and maintain Individualized Training Programs.
Conduct integration, functional and stress tests for database, web-based and handheld applications and hardware.
Achieve certification as an Internal PHT Auditor.
Education Minimum: BS, BA, or equivalent
Required Skills and Experience:
Minimum of 5-7 years of software quality assurance experience including creating test plans, performing ad hoc and scripted testing and maintaining detailed documentation.
Minimum of 1 year experience managing a software testing function.
Self-starter with the ability to work with little or no direct supervision, as well as the necessary communication skills to interface directly with the development staff and communicate effectively about project issues.
Experience finding, reproducing, logging and verifying software defects.
Extensive knowledge and experience testing web-based software applications.
Experience providing and seeking peer reviews of test plans to improve quality.
Ability to manage multiple projects simultaneously.
Experience working on projects for demanding clients and a commitment to meet tight timelines while helping the team produce high quality software.
Ability to carefully examine requirements specifications to anticipate quality issues and provide timely feedback when specifications are incomplete or inaccurate.
Working knowledge of at least one of the following programming languages; Visual Basic, Basic, C, C++, Java.
Working knowledge of software tools such as a Visual SourceSafe and Rational ClearQuest.
Ability to learn quickly, work in a team environment, and demonstrate a quality attitude.
Excellent oral and written communication skills.
Highly Desirable Skills and Experience:
Experience testing software for clinical trials or the pharmaceutical industry.
Software testing experience in a regulated environment (ISO 9001, FDA 21 CFR Part 11).
Experience with testing applications with hardware and software components for handheld devices such as Palm PDAs (Palm OS) and Windows Mobile devices.
Experience with applications that use a relational database back-end such as Microsoft SQL
Experience with Microsoft Office, especially Word, Excel, and Outlook.
||Boston, MA |
THIS JOB HAS EXPIRED