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Senior Quality Engineer Job

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Date: Sep 9, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations:

 

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 - Design Assurance

 

About the role:

Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.  Primary focus of this role will be the execution of design control deliverables associated with design file remediation and sustaining projects to meet European Union Medical Device Regulation (MDR) requirements. This position interfaces with cross functional teams to complete sustaining projects, design control deliverables, and activities to ensure MedSurg (Urology, Pelvic Health, and Endoscopy) products meet evolving standards in the European Union (EU).

This role ultimately provides quality engineering support to sustaining and improving current products on market, as well as new product development.  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, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities. Provides quality engineering support within technical development projects, continuous improvement product development projects, sustaining existing product families, or system/services support.

 

Your responsibilities include:

  • Act as key team member to the EU MDR transition team in 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. Including representation of the business in regulatory audits and supporting government agency questions.
  • Lead the execution of effective Risk Management deliverables to ensure compliance to ISO 14971 and demonstrates a primary commitment to patient safety. Lead project teams and franchises in the execution of Quality Deliverables such as Project Design & Development Plan, Post-Market Surveillance Plan, and Field Assessment Plan. Lead product Usability and Design validation efforts for new product development and design change projects. Specifically, in relation to achieving and continuity compliance to the EU MDR regulation.
  • Provide quality and compliance input to the project team for project decisions and deliverables (e.g. Design & Development Plan, User Needs, Design Input Requirements, Test Methods, Design Review, Design V&V, Usability Testing, SW Validation, Process Validation, Packaging and Labeling) whether internal, co-developed or externally manufactured. Provide quality and regulatory guidance to assure country specific compliance to the laws and regulations (specifically EU MDR) of the targeted market for distribution. Champions 100% compliance to Company Policy and SOP’s. 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.
  • 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 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, CAPA’s, PIR’s and Field Actions.
  • 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.
  • Act as team member in supporting quality disciplines, decisions, and practices.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Assure the development and execution of streamlined business systems, which effectively and efficiently comply with procedural and regulatory requirements and are robust to identify and resolve quality issues.  In this role, the candidate will specifically lead these types of initiatives for the achievement and ongoing compliance of the EU MDR regulation.
  • Advise management on potential improvements or enhancement to quality systems and processes in the company.

 

What we’re looking for in you:

• Minimum of a BS in Mechanical, Electrical, or Biomedical Engineering. 

• Minimum of 5-8 years of Medical Device design controls and risk management experience required.

• In depth familiarity with the FDA, ISO, MDD, and the medical device industry quality requirements associated with product design & development and product risk management.

Familiarity with the EU MDR regulation and Post Market Surveillance requirements

• 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.

• Strong communication (oral and written) and presentation skills.

• Familiar with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).

  • Expertise with Quality Planning and standards gap assessment

 

Preferred Qualifications:

  • MS degree preferred
  • Familiarity with the EU MDR Regulation
  • Focus on detailed work with emphasis on accuracy and completeness
  • Excellent organizational and planning skills; drives for results
  • High energy problem solver capable of driving items to closure

 

 

Requisition ID: 487576

 

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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