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Senior QA Engineer Job

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Date: Jul 26, 2021

Location: Arden Hills, MN, US, 55112

Company: Boston Scientific

 

 

 

Additional Locations: US-MN-Maple Grove; US-MA-Cambridge; US-MA-Marlborough; US-MA-Quincy; US-MN-Minnetonka

 

 

 

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.

 

 

 

 

 

About this role:

BSC-global position offering exposure to the products and Quality System of all BSC business units. Opportunity to restore and solidify government-regulator and physician-customer confidence in BSC products, at a time when a recent adverse event involving BSC product(s) may have inspired doubt.

 

Post Market Communications provides a focal point for private and public dissemination of Boston Scientific product performance information. A Quality Assurance Engineer in this role will prepare written product performance responses of high complexity to customers including government regulatory agencies, notified bodies, physicians, patients, sales representatives, and internal employees to promote or restore confidence in the quality and reliability of Boston Scientific products and services.

 

 

Your responsibilities will include:

  • Receives requests for product performance. Negotiates project priority and monitors progress to ensure timely response.
  • Carefully refines the topic of interest through clarifying questions, anticipation of audience need, and careful listening, and develops a response strategy.
  • Seeks out cross-functional subject matter experts and secures required technical and clinical information.
  • Drafts response, incorporating information from subject matter experts and approved product labeling, and adding original content based on product knowledge.
  • Coordinates review/edit/approval process per department procedure. Ensures accuracy, readability, and consistency.
  • Delivers final response to customer (or intermediary) and ensures documents are archived within the Complaint Management database and department drives.
  • Seeks opportunities to reduce workload by understanding any emerging patterns/trends among requests (e.g. current topics of interest, geographical or requestor trends).
  • Edits communication drafts prepared by others. Mentors Complaint Management Center in formulating product performance communication strategies and messages, including template responses.
  • Provides feedback to upstream responders to improve initial communications in an effort to reduce the need for future regulatory requests.
  • May prepare custom presentations or website-posted technical/training papers to meet customer need and to broaden delivery and effectiveness of Boston Scientific product performance messages.
  • Initiates and supports continuous improvement activities at a personal, department and cross-functional level.

 

 

What we’re looking for in you:

Minimum Qualifications

  • Bachelor’s degree plus four years of industry experience [Master’s degree + 2 years], or equivalent.
  • Strong communication, writing, editing, and presentation skills. 

Preferred Qualifications

  • Bachelor degree preferred in a science / health.
  • Medical device/regulated industry experience.
  • Familiarity with Boston Scientific products, including associated product labeling.
  • Previous communication experience with government regulators and physician-customers. 
  • Familiarity with complaint handling and Quality System processes.
  • Knowledge of anatomy/physiology associated with endoscopic, urologic, and men’s/women’s health. 
  • Project Management experience.
  • PC literacy in word processing, spreadsheets, presentation applications, and database management

 

 

 

 

 

 

Requisition ID: 480009

 

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: Minneapolis

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