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Senior Quality Engineer Job

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Date: Oct 2, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: (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.

 

Sr. Quality Engineer

 

About the role:
A Senior Design Assurance Quality Engineer is responsible for assuring all requirements for the Product Development Process (PDP), Risk Management, Design Controls, Usability Testing, and External Manufacturer Production Controls are met by: a.) Providing quality and compliance input to the project team for project decisions and deliverables (e.g. Design & Development Plan, Product Specification, Test Methods, Design Review, Design V&V, Usability Testing, SW Validation, Process Validation, and Labeling) whether internal, co-developed or externally manufactured,  b.) Leading the execution of Quality deliverables such as Risk Management Plan/Report, Hazard Analyses, Use and Design FMEA, Usability Testing, Design Validation, Quality Plans, and Field Assessment Plans, c.) Providing quality and compliance input and coaching for product development and/or 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, PIR’s and CAPA’s, and d.) Supporting Corporate Quality initiatives utilizing their PDP, Risk Management, and Design Controls expertise.

 

Your responsibilities include: 

  • Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applicable). 
  • Lead product usability and design validation efforts for new product development and design change projects.
  • Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country specific compliance to the laws and regulations of the targeted market for distribution.
  • Provide product specific supplier and co-development quality assurance expertise during supplier audits, and through approval of supplier PDP and Design Controls deliverables.
  • Measure and oversee the real-time continued quality of internal and external Component and Finished Good Suppliers.
  • Provide key quality trending information and data for Management Review as required.
  • 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).
  • Devise and 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.
  • Champions 100% compliance to Company Policy and SOP’s.
  • Advise management on potential improvements or enhancement to quality systems and processes in the company.
  • Support internal and external regulatory audits.

 
What we’re looking for in you:

  • BS in Mechanical or Biomedical Engineering; MS preferred.  
  • 5-8 years of Medical device engineering experience; 7 + years of medical device engineering experience preferred.
  • In depth familiarity with the FDA, ISO, MDD and the medical device industry quality requirements associated with product development, design controls, and product risk management.
  • Detailed understanding and working knowledge 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, EN ISO 14971, and EN 62366.
  • Strong communication and presentation skills.
  • Able to work in a fast paced, dynamic environment.
  • Competent with use of Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
  • Ability to travel approximately 10-15% of the time

 

 

 

 

Requisition ID: 503681

 

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, Senior Quality Engineer, Engineer, Engineering, Quality, Healthcare