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Senior Quality Engineer Job

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Date: Sep 23, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: US-MA-Marlborough


Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - 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.


Senior Quality Engineer


About the role:
Develops, establishes and maintains 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.  This position interfaces with cross functional teams to complete sustaining projects, design control deliverables, and activities to ensure Women’s Health products meet evolving standards in the European Union (EU) where applicable.  This role ultimately provides quality engineering support within sustaining exiting product families, continuous improvement product development projects, or ongoing quality system / post market support.
Your responsibilities include:

  • As a Senior Design Quality Assurance Engineer (Sr. DQA), this candidate would lead the sustaining efforts of Women's Health products (eg. EN 13485 / CFR820).
  • Act as key team member to EU MDR transition teams updating and bringing Design History Files to state-of-the-art readiness including risk management and Post Market Surveillance activities. Activates may include product file remediation, submission support and supporting regulatory EU MDR submissions. 
  • Own Risk Management planning, reporting and the development of critical risk documentation in compliance with Boston Scientific procedures and external standards (eg. EN 14971).     
  • Own Usability Engineering and planning documentation (eg. EN 62366/ISO 62366)
  • Interface with the core team and support manufacturing operation efforts for both product and packaging designs.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
  • Provide quality and compliance support during regulatory audits and responses to government agency questions.
  • Lead CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies). Provide key quality trending information and data for Management Review and Complaint Reviews, as applicable.

What we’re looking for in you:

  • BS in Biomedical Engineering or related discipline.
  • Minimum of 5-8 years of Medical Device experience.
  • In depth familiarity with the FDA, ISO, MDD, and the medical device industry quality requirements associated with product design & development and product risk management.
  • Ability to work in a fast paced, dynamic environment.
  • Detailed understanding of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, and EN ISO 14971.
  • High energy problem solver capable of driving items to closure.
  • Strong communication (oral and written) and presentation skills.
  • Familiar with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
  • Experience with polymers or medical device implants preferred





Requisition ID: 483322


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.


Nearest Major Market: Boston

Job Segment: Quality Engineer, Medical, Manufacturing Engineer, Senior Quality Engineer, Engineering, Quality, Healthcare