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Manager, Software Quality Assurance (Software Engineering)

Company: TerumoBCT, Inc.
Location: Lakewood
Posted on: April 13, 2018

Job Description:

Requisition ID: 14861



Manages the success of the Software Quality Assurance Team to ensure the delivery and testing of quality software and medical systems, including medical devices with embedded software and data management software applications associated with those devices. Analytical and problem solving skills are needed to contribute to the quality of the product throughout the development life cycle and experienced in transforming development processes and teams resulting in improved software reliability and predictability.



ESSENTIAL DUTIES

* Manages and provides leadership for the functional group s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.

* Manage the full software quality lifecycle for multiple projects

* Responsible for multiple concurrent product releases including project management, planning, resource management, application of business and company priorities and staying within departmental budgets.

* Must be able to articulate business and strategic information as well as tactical levels of acumen.

* Must have the technical aptitude to practice full life-cycle testing in, software applications and embedded environments using both manual and automated techniques.

* Responsible for applying technical and business knowledge to analyze, recommend, and implement policies, procedures, and standards in various technology areas and assure these align with Business strategy and goals.

* In depth understanding of software engineering principles and have the ability to apply this understanding to formulate test strategies for medical devices.

* Understand and provide support for the internal and external audit processes for releasing products in a regulated environment

* Interpret standards, manage risk analysis for human safety standards, understand testing protocols for various engineering disciplines, formal system validation activities while ensuring the adherence to established industry and quality principles.

* Manage Global releases and apply SQA testing to make sure products meet various country regulatory requirements.

* Works collaboratively as a leader with peers and direct reports to ensure activities are performed within the area of responsibility and are supporting the business, this includes collaboration with management to gain strategic perspective and manage projects to the customer end goal.



OTHER DUTIES AND RESPONSIBILITIES

* Assures clear communications both internally and externally around the functions for which he/she is responsible.



MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor s degree in Computer Science or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.



Experience

Minimum 10 years experience

* Experience preferred in the SQA field with proven understanding of all phases of the development lifecycle including scoping, design, construction, integration and testing.

* Previous experience in a regulated environment with ability to interpret and incorporate into software quality industry standards preferred.



Skills

* Knowledge and use of relevant software applications and skills to use them effectively.

* Demonstrated ability to communicate effectively both verbally and in writing.

* Knowledge in testing methodologies and theories, test plan development, test case design, test case execution practices; data collection and root cause analysis techniques, and reporting practices.

* Demonstrated ability to manage multiple projects utilizing appropriate tools and systems to support project management of all project sizes while managing to the business priorities and business needs.

* Demonstrated ability to utilize effective leadership, analytical skills, and mentoring of others while building, coaching and managing teams of all sizes.

* Demonstrated industry knowledge in SQA testing, and/or GMP/IEEE/ISO 9000 standards, documentation standards, testing scripts/plans and protocols, safety risk analysis, user interface testing supporting the human factor related to issues, software traceability, software development processes and continuous improvements, SQA continuous process improvements and accountability, risk management techniques and how to incorporate these methods/processes throughout the device lifecycle to ensure quality products and overall patient safety.

* Skilled in prioritizing, goal setting and drive for results, time management, effective use of resources and ability to work on multiple projects concurrently and collaborate with all disciplines inside and outside of the SQA team.

* Demonstrated ability to evolve and implement multiple business and process disciplines while maintaining departmental productivity and make recommendations to improve Software Quality Assurance processes, practices , procedures, product functionality, reliability, and overall quality.

* Skilled in promoting SQA methodology, testing procedures and project status ensuring that the SQA team and/or leads are accurately adhering to updating status and deliverables as required.

* Understanding and previous use of HP Quality Center and implementation of test systems using Quality Center,

Perforce, MSDN, IBM Rationale Requisite Pro, MKS source code & release management, or other automated testing and release management tools, issue tracker tools, PL/SQL and automated test tools, familiarity with VxWorks or other embedded OS, use of VMs to support testing.



-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.



PHYSICAL REQUIREMENTS

* Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

* The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.

* Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.







We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.



We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks. As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace. For more information about Terumo BCT, visit our website www.terumobct.com/careers.

Join Terumo BCT as we unlock the potential of blood. We are a global leader in blood component and cellular technologies, and the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.



As the largest medical device manufacturing company headquartered in Colorado, we are home to more than 2,300 associates and our products are in use in more than 125 countries and territories. Our Global footprint includes more than 5,500 associates and partners with regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.



Our company has almost $1B

Keywords: TerumoBCT, Inc., Denver, Manager, Software Quality Assurance (Software Engineering), IT / Software / Systems, Lakewood, Colorado

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