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Senior Quality Engineer-Design Assurance Job

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Date: Oct 1, 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 Post Market Reporting assessments (Periodic Safety Updates) including but not limited to all associated design control and quality system deliverables related with execution.  The role identifies, analyzes, investigates, monitors and documents trends at a product performance level for post marketing surveillance data as part of the EU MDR reporting requirements. As a Senior Engineer in this space, this role is responsible for leading the analysis, investigation, drawing conclusions and leading divisional partners in assessment and/or execution of potential non-conformances and continuous improvement. 

 

The role will identify, coordinate, and execute project priorities based on business and department objectives and at times at the Global BSC level to ensure MedSurg (Urology, Pelvic Health, and Endoscopy) products meet evolving standards in the European Union (EU). Responsible for identifying and helping with implementing continuous improvements to improve product performance and the post market support processes.  

 

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.

 

This role provides visibility across site, cross division and with divisional leadership.  

 

Your responsibilities include:

  • Act as lead team member in analyzing customer complaints, compliance events, clinical data and post marketing surveillance data by examining for patterns, trends and investigating when necessary.
  • Lead in the investigation of potential and/or identified trends or data issues with cross-functional teams across division(s).  
  • Manage potential actions by updating the Post Market report at appropriate intervals and levels by performing, when necessary, a Health Risk Analysis and/or Risk Management Analysis reviews. 
  • Documenting data reviews, trend analysis, escalations and actions as an output in formal regulatory submission report (PSUR) for Notified Body review and agreement.
  • Communicating product performance by formal presentations to management, cross-functional team members, committees and/or design teams, driving the execution of written product performance reports.
  • Focusing on continuous improvement by championing and fostering the execution of projects within the local and Global Design Assurance and Post Market organizations to continue to improve process and product performance. 
  • Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
  • Demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • Provides leadership and key mentorship to junior staff though 
  • Act as key team member to the EU MDR transition team in updating and bringing Post Market Reporting to state-of-the-art readiness including associated risk management. Activates may include 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 including but not limited to Post-Market Surveillance Plan & Report, Field Assessment Plan and Clinical Evaluation Reports. 
  • 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 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 and country specific regulations as it relates to Post Market data. 
  • 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, or related discipline   
  • Minimum of 5-8 years of Medical Device design controls, post market and risk management experience required.
  • 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, specifically Excel, and Minitab Statistical Analysis software (or equivalent).
  • Expertise with Quality Planning, Quality System Requirements and standards gap assessment 
  • 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
  • Travel approximately 10-15% of the time

 

Preferred Qualifications:

  • MS degree preferred
  • Familiarity with the EU MDR regulation and Post Market Surveillance requirements 
     

 

 

Requisition ID: 503117

 

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.

 


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