ERT

Team Lead, Software Quality Engineering

Job Location US-PA-Pittsburgh
Shift
full time
Type
Regular Full-Time

Overview

A hands-on leadership role with responsibility in managing employees, tasks, and project deliverables for a team of SQEs with individuals located on-site.

Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

 

  1. Writes, reviews and approves validation plans, traceability matrices, test scripts and validation reports in accordance with application development efforts and pertinent SOPs and Work Instructions.
  2. Maintains and developsSOPs, WINs, and templates as directed by the Manager, Project Software Quality Engineering.
  3. Participates in the review of other relevant SOPs, WINs, and templates.
  4. Assures accurate and timely input of Project SQE personnel into the time reporting system and approves timesheets upon completion.
  5. Attends project meetings and assesses SQE effort for multiple projects running simultaneously.
  6. Participates in audits conducted by external parties as required by the Director of Quality Management & Compliance; responds to audit findings and observations as necessary.
  7. Conducts and/or participates in internal audits to ensure compliance with ERT’s Quality Management System, FDA regulations, ISO standards, and other regulatory requirements.
  8. Oversees requirements and designs specification reviews.
  9. Serves as a subject matter expert in cross-functional collaborations with other ERT departments and groups in the development of best practices and process improvements.

 

OTHER DUTIES AND RESPONSIBILITIES:

 

  1. Ensures that appropriate training is conducted on departmental and corporate Standard Operating Procedures (SOPs), Work Instructions (WINs), and templates.
  2. Ensures that appropriate Policies (POLs), SOPs, WINs, and templates are followed and adhered to by the Project SQEs and indirectly by the offshore Project Quality teams.
  3. Partners with HR on hiring, development, and performance management of team members.
  4. Monitors the performance of SQEs reporting and offshore testing resources as needed and works with the Manager, Project Software Quality Engineering to address any issues that occur.
  5. Prepares periodic reports for management as requested summarizing performance metrics.
  6. Provides subject matter expertise for assigned processes to users as necessary.
  7. Is responsible for cross functional collaboration with manufacturing operations, marketing, sales, regulatory and clinical functions.
  8. Re-assigns SQEs/Testing resources as needed on various projects.
  9. Supports Squad Leads as needed in Quality Engineering tasks.
  10. Directly supervises the performance of the Project SQE team, providing leadership and solving technical challenges as necessary.
  11. Helps hire, train and manage SQE personnel.
  12. Provides performance appraisals feedback to Managers.
  13. Manages execution of Individualized Training Programs by the Project SQEs.
  14. Assigns tasks to the project development team of SQEs and monitors their efficiency.
  15. Oversees assignment and coordination of tasks performed by offshore Project Quality teams and monitors their efficiency.
  16. Prepares and/or maintains position descriptions, competency models, and training materials for the Project SQE group, as directed by the Manager, Project Software Quality Engineering.
  17. Promotes and maintains a positive, results oriented work environment, building partnerships and modeling teamwork.
  18. Assists the SQE Managers/Director in meeting corporate objectives

Qualifications

QUALIFICATIONS AND SKILLS NEEDED:

 

Education:

  • BS, BA or equivalent in an Information Technology or related field required.

 Experience:

  • Minimum of 5 years of software quality assurance and/or equivalent experience.
  • Minimum of 2 years + experience in managing projects with a proven track record to deliver quality, on-time and in-budget.

The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications.

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