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Quality Engineer II Job

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Date: Sep 14, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: (n/a)


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.

Quality Engineer II – Design Assurance, Sustaining Engineering
About this role:
A Design Assurance Quality Sustaining Engineer II is responsible for assuring all requirements are met for the Product Lifecycle Process (PLCP), Risk Management, Design Controls and Usability Testing in support of sustaining and improving current products on the market. Works in fast paced Cross-Functional Teams to maintain and support quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities.


Your responsibilities include:
Design Controls: Providing quality and compliance input to the project team for project decisions and deliverables (e.g. Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Review, Design V&V, Usability Testing, SW Validation, Process Validation, and Labeling) whether internal, co-developed or externally manufactured. Provide quality and regulatory guidance to assure country specific compliance to the laws and regulations of the targeted market for distribution. Champions 100% compliance to Company Policy and SOP’s. Support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed internal quality as well as statutory requirements.
Product Support: Provide key quality trending information and data for Management Review and Complaint Reviews. Provide quality and compliance input for post market product sustaining activities, such as design changes, supplier auditing and surveillance, design concessions, product CE marking and safety certification, customer complaint investigations, NCEP’s, CAPA’s, PIR’s and Field Actions
Champion Continuous Improvement: Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies). Lead the implementation activities for post-market surveillance, product feedback and corrective and preventive action programs. assurances, process controls, and CAPAs / systems designed to meet or exceed internal and external requirements.
Audit Support: Support internal and external regulatory audits in a research capacity.


What we’re looking for in you:
A commitment to our Vision to be a trusted design partner of choice that uses our specialized knowledge to deliver quality results for our customers by being Engaged, Communicative, Thoughtful, Proactive, Trustworthy and a Steward of Best Practice.   
Minimum Qualifications

  • BS in Mechanical, Electrical, or Biomedical Engineering.  MS degree preferred.
  • 3 years of Medical Device quality experience, design controls and risk management experience preferred
  • In depth familiarity with the FDA, ISO, MDD and the medical device industry quality requirements associated with product design & development and product risk management.
  • Detailed understanding of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EUMDR, EN ISO 13485, and EN ISO 14971.
  • Strong communication (oral and written) and presentation skills.
  • Familiar with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent). 


Requisition ID: 495796


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

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