Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
Advancing possibilities for a brighter tomorrow
Boston Scientific is seeking a highly motivated Software QA Engineer II on a permanent basis to join our team.
Job Purpose:
As the S/W QA Engineer you will develop, establish and maintain quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provide focused quality engineering support within new product development, operational, or system/services support.
Key Responsibilities:
- Ensures that Equipment & Software Qualification is carried out in compliance with Global & Site Policies, SOPs & WIs.
- Ensures that best software validation practices are employed by all departments so that Equipment & Software systems which have an impact on product or process quality are developed, validated and documented in a manner which provides assurance that the system conforms to both established Regulatory, Quality System, and technical requirements.
- Provides guidance to teams on Non-Device Software Lifecycle processes at BSC including Equipment with Software, Software Only Systems, Spreadsheet Validation, Data Reporting Software, Artificial Intelligence Applications etc).
- Reviews and approves all deliverables associated with Equipment & Software Qualification Lifecycle to ensure Equipment & Software is qualified per it intended use (e.g. QP, PRA/EHA, EFS, EQP, SCS, EQR) including deliverables from other Software Qualification Lifecycles as applicable.
- Ensures that all new Equipment & Software, and updates to existing Equipment & Software systems are qualified according to established BSC Change Control processes.
- Ensures that all discrepancies and deviations encountered in Equipment & Software Qualification projects are adequately controlled, documented and addressed by the Project Team.
- Provides guidance and collaborates when required with project teams on associated documentation for equipment and systems.
- Provides software validation/compliance/part 11/ data integrity guidance in accordance with BSC policies and SOPs and industry and regulatory standards.
- Provides training to employees across various functions on Equipment & Software validation to ensure improved competency.
- Drives a culture of Right First Time to support patient and product safety while ensuring increased time efficiency and cost effectiveness for the business.
- Participates in Validation project teams and assists in determining project schedules. Works with teams and other departments across the plant to ensure project adherence.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Possess technical competency to drive improvement in the Software Quality department processes through automation.
- Supports department initiatives in driving Business Service Excellence and VIP initiatives
Education & Experience:
- Level 8 Hons Bachelor Degree in Software Engineering, Quality or relevant discipline.
- Minimum 3years experience in a similar role.
- Requires expanded conceptual and technical and/or functional knowledge in own job function
- Broadens capabilities in applying concepts in job function
- Requires technical and/or functional knowledge or the ability to learn for the following:
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- Languages: (C#, C++, Java, VB.Net, Python, etc.).
- Database (SQL).
- Power Apps: (Power BI, Power Automate etc).
- Artificial Intelligence Applications.
Compliance Requirements:
- Working knowledge of business and industry practices and company processes to accomplish own work.
- Uses and exercises judgment to solve problems in straightforward situations and determine appropriate action/solutions.
- Impacts quality of own work and the work of others on the team; works within guidelines and policies.
- Explain factual information of limited complexity to others in straightforward situations
- Experience organising, presenting and explaining data/ information, primarily to internal audiences
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
To search and apply for open positions, visit: https://bostonscientific.eightfold.ai/careers
At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email TalentAcquisitionIre@bsci.com
