Software Quality Assurance Manager Biomedix Vascular Solutions

The manager will lead a team of engineers and developers who are involved in the full life cycle of development of software from inception, design, installation, and testing to the field deployment of products. In addition, the position has a forward looking research and development aspect, to learn, adapt, and incorporate new techniques into BioMedix? product line in collaboration with research personnel at BioMedix.



Summary:

The Manager of the Quality Assurance department is responsible for the management of all aspects of Software Quality Assurance activities at BioMedix. The Manager will work with minimal guidance to support the design, development, testing, and market release of software used with all medical device and healthcare IT products. The manager will contribute to formulating the processes, tools, methods, and procedures used to test software applications in conformance with ISO 13485, the QSR, and BioMedix?s quality system.

The Manager will also formulate verification & validation of software requirements, traceability & testability plans and documents and ensure that best-in-class methods and processes are employed. He/she will collaborate with Software Engineering in furtherance of the goal of achieving high quality system and software design. The Manager will use metrics, historical data, and other tools to work for continuous improvement of people, processes, and products.

The Manager will also provide expertise and guidance related to appraisals of programming languages and systems, third party libraries (OTS software), and related technology. He/she will work to ensure that corrective action measures meet acceptable quality/reliability standards. The Manager will also contribute to continuous improvement efforts of BioMedix?s quality system.

The Software Quality Assurance Manager will be responsible for:


When appropriate, the manager will advise on changes and their implementation and will provide training, tools, and techniques to enable others to achieve high quality standards.
The manager will directly supervise quality assurance engineers and tester including the preparation and delivery of staff performance evaluations and formulation of career development activities.
Manage department activities relating to project management (with focus on on-time delivery), budget formulation, and resource allocation.
Actively participate in product development cycle by reviewing software project documentation, participating in product risk assessments, and working closely with product development personnel to develop appropriate verification and validation testing requirements.
Work cross-functionally to implement improvements to the software life cycle including the establishment of risk management as an integral part of the quality management system.
Identify and measure software process metrics for software product development.
Develop, analyze, and monitor metrics pertaining to software defects uncovered during development, testing and post-release.
Recommend and lead corrective/preventative actions to improve software product quality.
Ensure that Documentation & findings are completed in a timely manner and in accordance with FDA & European regulatory agency standards and procedures.





Objectives:


The manager of the Software Quality Assurance team will provide the definition, development, and deployment of the product quality assurance strategy addressing all phases of product development. He/she will liaise with other functional managers and staff throughout the organization to ensure that the QA system is functioning properly.


Requirements:


BS Engineering, Computer Science, or an equivalent discipline
10+ years of experience in quality assurance for the development of software-based products
5+ years of experience managing technical personnel
Experience with software-related hardware interfaces
Experience with one or more of C/C++, Visual C++,MFC, C#, and VB.Net
Experience with WINDOWS applications and familiarity with embedded applications
Strong technical skills in requirements definition
Experience in using version management tools like CMSynergy/ClearCase/CVS/Subversion
Experience with project scheduling and resource allocation
Experience with Design of Experiments
Statistical Analysis with Respect to DoE and Testing
Experience in verifying hardware and software designs through testing and qualification
Experience in writing and executing test plans related to software and hardware combined products.
Experience in implementing ongoing quality improvement processes working with interdepartmental teamsStrong leadership skills that inspire team confidence/respect while motivating team members in a creative and effective manner
Strong ability to anticipate and recognize product release problems and to take corrective action, escalating as needed, to resolve and achieve commitments
Strong analytical skills and experience with implementation and administration of quality assurance metrics, such as defect profiles and performance to entry/exit criteria
Strong understanding of different product development life cycles and contemporary software quality assurance processes and automated tools.
Experience with FDA related Quality System Regulation Processes ? 21CFR820
Experience with Quality Management ? ISO 9001 & 13485
Experience with Harmonized Standard for Risk Management ? ISO 14971
Experience with EU Medical Device Requirements ? Council Directive 93/42/EEC
Experience with Harmonized Standard for Medical Device Software Development ?ISO 62304
Experience creating and revising standard Operating Procedures (SOPs) and other documentation to support the Quality System with regards to software and system design testing
Skilled in product risk assessment, requirements management and tracing, defect tracking, configuration management techniques, and how they are applied in the software development lifecycle
Fluency in spoken and written English
Experience with MS WORD, Excel, and other OFFICE software
Modest travel/ domestic U.S.

Additional/ Desirable Skills/Attributes:

M.S./ PhD in management, engineering, computer science, mathematics, or other technology discipline
Strong technical skills in designing code, testing, and debugging.
Formal training in Lean, Six Sigma, and Kaizen methods at the green belt or greater
Experience with products similar to Requisite Pro, DOORS, etc.
American Society For Quality, Certified Software Quality Engineer (CSQE)
Knowledge in one or more of the following areas: Communication protocols (TCP/IP, wireless)
Ability to read technical documentation (e.g. electrical schematics, technical datasheets)
Experience in working with electrical hardware test equipment (oscilloscopes, logic analyzers, etc.)
Medical Electrical Equipment ? EN 60601
ANSI/AAMI software standards and AAMI technical information reports


Travel:

Up to 25%

Location:	4215 White Bear Parkway St. Paul, MN 55110 United States