Software Quality Engineering Manager
Covidien
Location:
Nellcor Puritan Bennett, now the Respiratory and Monitoring
Solutions (RMS) business unit of Covidien, formerly Tyco Healthcare is
relocating its operations to
In addition to Respiratory and Monitoring Solutions, Covidien also manufactures, distributes and services a diverse range of industry-leading product lines, including surgical devices, energy-based devices, pharmaceutical products, imaging solutions, patient care and safety products, and medical supplies.
For more information, visit us as www.covidien.com.
ESSENTIAL FUNCTIONS:
•Oversee and manage Software Quality Assurance Engineers ensuring that software used in the development, manufacturing, and as part of medical devices is developed according to good design practices and follows the corresponding requirements set forth by local procedures, regulatory authorities and notified bodies. (e.g. FDA and TUV).
•Manage Manufacturing Software Quality Engineer providing oversight, review and approval of manufacturing division computerized system validations.
•Manage department resource allocation across multiple product lines.
•Write software process procedures and guidance documentation for software development lifecycle.
•Interact with FDA inspectors and auditing body agencies during audits.
•Drive change, demonstrate effective decision making, and provide direction for quality operations.
•Provide guidance and advancement opportunities for department employees.
MINIMUM REQUIREMENTS:
Bachelor of Science degree in Electronics Engineering, Computer Science, or Computer Engineering
6+ years experience in software test or software quality engineering with embedded software as part of a medical device
Experience in a management role
Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
Skilled in product risk assessment (ISO 14971), requirements management and tracing, defect tracking, configuration management techniques, and how they are applied in the software development lifecycle
Understanding of current Software Quality techniques, software industry standards (e.g. ISO, IEEE, CMMI), and FDA Quality System Regulations and their impact on internal procedures, software quality, safety and efficacy of products
Working knowledge of C, C++
CSQE Certification
TO APPLY: Please submit resume to Deborah.Cason@Covidien.com
EEO/AA