Software Quality Assurance Engineer I

Additional Location(s): N/A

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.

About This Role:

Develops, establishes, and maintains software quality assurance methodologies, systems, and practices which meet Boston Scientific, 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. Provides focused software quality assurance support within new product development, operational, or system/services support.

Your Responsibilities Will Include:

• Work within a team of Software Quality Assurance Engineers that support manufacturing, Laboratory, R&D, and IT systems.
• Actively contribute to all aspects of Software Quality Assurance activities in FDA-Regulated Medical Device environment and ensure that software verification and validation is carried out in compliance with site/corporate policies and procedures.
• Perform independent review of design, development, and testing of software/firmware used in Boston Scientific Interventional Cardiology and Peripheral Interventional product lines during their entire System Development Life Cycle, from the requirements gathering phase to the retirement phase.
• Review and approve documentation associated with qualification planning, intended use, user requirements, hazard analysis, functional and design specifications, design reviews, test protocols, requirements trace matrix and qualification report along with support documentation for equipment and systems.
• Review and approve changes to existing systems from a Software QA perspective, making sure changes are implemented in compliance with internal procedures and external standards.
• Review test results for compliance with Good Documentation Practices and ensure that all test discrepancies to acceptance criteria are adequately controlled, documented, and addressed.
• Ensure that best software QA practices are employed by all departments so that software/firmware based systems are developed, qualified, and maintained in a manner which provides assurance that the system conforms to both internal and external requirements.
• As required, support site audits, non-conforming events, and CAPA’s.
• Establish and promote a work environment that supports the Quality Policy and Quality System.
• Establish and cultivate internal business relationships to facilitate completion of tasks. May participate in project teams.

Required Qualifications

• Bachelor’s degree or higher in science, engineering, or software discipline.
• Knowledge of system development life cycle (SDLC), preferably with automated manufacturing and computerized lab systems.
• Must possess excellent organizational skills and clear communication skills, both written and verbal.
• High level of attention to detail and compliance; ability to effectively support multiple high-priority deliverables at once.

Preferred Qualifications

• 1-2 years of related work experience in Software QA and/or computer systems validation.
• Experience working in FDA or related regulated industry.
• Practical knowledge of 21 CFR Part 11 (electronic records/electronic signature).
• Experience supporting manufacturing of medical devices.
• Team-oriented with people skills and positive, can-do attitude in dealing with a large number of customers, from various departments (Engineering, R&D, Manufacturing, Regulatory, and Labs, etc).
• Hands-on approach, self-motivated with a passion for solving problems.

Requisition ID: 557975

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 (NYSE: BSX) 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!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why 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 maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.