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QA Engineer II Job

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Date: Jun 9, 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.

 

Quality Engineer II, CIS
 
About the role
:
The CIS Quality Engineer II is an active participant within the MedSurg Complaint Investigation Site (CIS) and Data Reporting/Trending.  This role is responsible for managing the customer complaint failure analysis process for assigned product families; coordinating additional investigation with Business Unit Quality and/or the Supplied Finished Medical Device Manufacturer (SFMD); monitoring trending of product performance data and providing interpretive summaries of results; ensuring compliance with policy, procedures, and regulations applicable to Post Market Surveillance complaint handling, and working with BU Quality and SFMD partners to manage CAPA issues associated with complaints. Identify & implement Post Market Monitoring workstream improvements to increase the effectiveness, integrity, and/or timely management of complaint data monitoring, trending and reporting.  Provide subject matter expertise to crossfunctional personnel involved in complaint related processes and workstreams, including Complaint Review Board and Management Review Board.


Your responsibilities include:

  • Sustain product complaint investigation activities for the Complaint Investigation Site (CIS) for assigned product families.
  • Ability to work independently while maintaining compliance in a fast-paced, dynamic setting.
  • Apply engineering principles to the analysis of complaint medical devices. 
  • Interface with intra/inter-site personnel to facilitate timely analysis of customer complaints and/or returned product.
  • Manage failure investigations including probable cause determinations with thorough, accurate, and timely documentation of findings.
  • Work closely with BSC Design Assurance/Sustaining Engineering on complaint product evaluation and provide detailed analysis of results as well as identify and recommend actions to cross functional teams for resolving device issues.
  • Work with Sourced Finished Medical Device (SFMD) partners to drive investigation closure.
  • Assist SFMD partners to conduct on-site failure investigations and visits as needed.
  • Participate in the development of protocols/plans/procedures/requirements for testing of returned customer complaint units in support of company’s quality program.
  • Apply existing techniques and procedures with recommendations and implementation of modification for improved efficiency or develop new analytical methods and techniques.
  • Promote Good Laboratory Practices and comply with site safety and health hazard requirements when working in the lab and when working with lab personnel.
  • Become proficient in the use and maintenance of applicable equipment and/or tools.
  • Prepare for and participate in complaint Signal Escalation Review & Complaint Review Board and present data when applicable.
  • Support internal/external audits, which may include auditor facing activities.
  • Provide technical training and support of junior engineers.
  • Partner with BU Quality, Complaint Investigation Sites (CIS), Complaint Management Centers (CMCs) to ensure business data reporting requirements are met. 
  • Ensure technical, reporting and analytical expertise in reviewing trends of product quality complaints. 
  • Apply and improve existing statistical methodologies to trend/monitor product/process performance.
  • Prepare for and participate in the complaint signal escalation process (ESE/SER/SEF) in support of monthly and quarterly report out forums (CRB/QMR).

 

What we’re looking for in you:

  • BS/BA in Engineering and/or Science Related discipline.
  • 3-5 years in Quality role.
  • 1+ years in the medical device industry OR solid background in QSR and MDD Quality System requirements.
  • Understanding of data trending, product performance monitoring and application of statistical methodologies to analyze/interpret data.
  • Skills in Excel, and PowerPoint to query, trend, analyze, interpret, and present data.
  • Skills in the utilization of relational databases, SQL, Visual Basic and Power BI (a plus)
  • Understanding of regulatory requirement relating to the medical device industry.
  • Proficiency in MS-Office (Word, Excel, PowerPoint, Project, Visio).
  • This position is in an office environment, with interaction with laboratories, BSC plants and external suppliers.
  • Able to communicate at all organizational levels both within BSC and with outside companies.
  • Able to work well in a team environment with peer group.
  • Travel may be required 5-15%
     

 

Requisition ID: 480503

 

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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