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Quality Systems Engineer II - Software Quality Assurance (Remote)

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Remote in Country
Onsite Location(s): 

Marlborough, MA, US, 01752

Additional Location(s): This position can be remote or located on any US Boston Scientific campus.

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 the role: 
The Quality Systems Engineer II - Software Quality Systems Engineer II is a global role that focuses on two main areas of responsibility. 

  • Remote Case Technology Support – partner with the remote Case Support (RCS) Center of Excellence to accelerate and enhance the global rollout of remote technology software in the areas that provide transformative clinical support through remote & hybrid customer experiences to support clinicians in the delivery of the best care and outcomes to patients.
  • Software Auditing & Vendor Management - support Boston Scientific's software vendors by auditing and supporting the maintenance of the software vendor auditing process. 

These will be the two main activities with additional opportunities for growth within the software cybersecurity space where it is expected to support the development, establishment, and maintenance of quality-engineering procedures which meet BSC, customer and regulatory requirements related to securely designing and maintaining medical devices. This role will work with colleagues in IT, Supplier Management, Clinical, Legal, Regulatory Affairs, Software Engineering, and Software Quality. This is a learning role with mentorship, guidance, and direction to reach the efforts above. Join this team, grow your skillset, and become a valued member! 

Your responsibilities will include:

  • Creates, manages, and maintains compliant processes including SOPs and work instructions that enable the delivery of Digital Technology initiatives such as ‘Remote Digital Support’ and ‘Telehealth’ that align with the changing customer needs for the delivery of patient care using BSC Therapies and Products.
  • Plays a key role in vendor management by identifying the quality system needs from a vendor and ensures that vendors are qualified in a manner that enables smooth integration with the BSC quality system including performing SDLC Assessments for non-device and device software vendors.
  • Applies knowledge of the quality system and familiarity with various software development methodologies to influence process development and improvement strategies that balance quality requirements including agile development methodology. 
  • Leadership of cross-functional projects teams using project management best practices to effectively coordinate activities, communicate progress, collaborate on key deliverables, and meet critical phase timelines.
  • Driving continuous improvement and globalization by gaining alignment across multiple functional departments while meeting BSC and regulation requirements.
  • Facilitate meetings with partners in marketing, regulatory, legal, supplier management and product development to drive actions to completion. 
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues.
  • Participates or leads in appropriate BSC Communities of Practice to ensure the global processes continuously execute process outputs at the highest industry/company level and anticipates emerging regulatory lines of questioning. 

 What we are looking for in you:

Minimal qualifications: 

  • Bachelor’s level degree in Science/Engineering/Computer Science/Software Engineering discipline 
  • 2-4 years of related experience, including experience supporting Quality Systems for Health Software or related discipline
  • Experience in working with ‘Agile’ software development methodologies.
  • Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, CFR Part 11, and cGxP for Medical Devices
  • Must have a good understanding of quality system requirements and how each quality system element connects.
  • Software auditing experience
  • Comfortable speaking and presenting to leadership 
  • Strong written and verbal communication skills 
  • Creative and innovative thinking skills 
  • Experience managing projects and project deliverables to completion 
  • Comfortable working independently and as part of a cross-functional team 
  • Ability to manage multiple priorities 

Preferred qualifications:

  • Clinical background or knowledge of clinical evaluations beneficial
  • ASQ CQA (Certified Quality Auditor)
  • Basic Understanding of HIPAA/GDPR and data security regulations beneficial
  • Some experience/knowledge of Cybersecurity and related Security Risk Analysis
  • Experience/Understanding of risk management as per ISO 14971
  • Experience with Remote Technology (e.g., Virtual Care, Augmented Reality, Smart Glasses), implementation or similar technology an advantage.
  • Experience with CAPA, Vendor Controls, Complaint Handling and External Audits
  • Experience working with a diverse population of internal and external customers 

#LI-Remote

 

Requisition ID: 535127

 

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.


Nearest Major Market: Boston

Job Segment: Compliance, Regulatory Affairs, QA Engineer, Quality Engineer, Medical Device, Legal, Engineering, Healthcare

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