Mgr, Division Software Quality Engineering
Job Description Summary
The UCC Software Quality Manager leads their team in efforts to manage new and existing software quality efforts in the Urology and Critical Care Division. In this role, the Quality Manager partners with each franchise to integrate quality software policy, procedures, and tools with the impacted processes of the quality system such as design control, risk management and complaint incident response. The role also contributes to future definition of software policies and procedures across UCC.
The candidate must be an effective communicator and problem-solver. They need strong leadership skills with a history of providing direction and mentorship to others. Lastly, the candidate must possess software knowledge in the regulated medical industry.
- Leads a team of software quality engineers to ensure compliance to software policies and procedures.
- Collaborates with other software teams in the organization on technical implementations and timelines
- Works with UCC project leaders to evolve and develop the division meeting technology, data, security, and privacy regulations
- Support software validations for design centers and manufacturing sites as needed, own software validations for quality management.
- Act as, or manage a, core team member for capital medical products representing software quality
- Participates in design and technology reviews
- Establishes and monitors staff development plans and goals
- Travels to other BD locations to carry out the duties described above, approximately 15% travel.
- BS degree in Computer Science, Computer Engineering or a related Engineering discipline; or equivalent experience.
- 5+ years of experience
- Minimum of 2 years’ experience leading teams and/or managing direct reports
- Experience with IEC 62304 compliance
- C, C++ and/or C#
- ALM/Quality Center
- Experience software designing and coding
- Experience with Software Configuration Management
- Experience with Requirement Managements
- Experience with Issue Tracking tools
- Experience working in a regulated (FDA) environment
Primary Work LocationUSA CO - Louisville
Additional LocationsUSA GA - Covington BMD
Work ShiftUS BD 1st Shift 8am-430pm (United States of America)
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