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Senior QA Engineer Job

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Date: Feb 11, 2019

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: (n/a)

 

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

Senior QA Engineer

 

About the role:

Develops, establishes and maintains quality trending methodologies, systems, and practices which meet BSC and regulatory requirements.   Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.  Provides focused quality engineering support, operational, or system/services support.  Functional Engineering Roles include: Design Assurance, Operations Quality, Software Engineering, Supplier Assurance, Product Analysis, Metrology, Microbiologist, Chemist.

 

Your responsibilities will include:

  • Provides leadership role on championing departmental or cross-functional initiatives.
  • Coordinate and maintain Quality System data to assist senior leaders in making critical assessment of the health of the quality system by executing the required elements: including data collection, data base population, conducting analysis, generating reports, creating presentations, participating in core team meetings, and documentation through meeting minutes or released quality documents.
  • Provides project direction, coaching, and mentoring for analysts and divisional trending teams.
  • Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
  • Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
  • Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.

 

What we’re looking for in you:

Minimum Qualifications

  • Bachelor’s Degree in the Engineering or Science field, plus 6-9 years of related experience or an equivalent combination of education and work experience.
  • Comprehensive understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485.
  • Strong analytical skills and working knowledge of Trackwise and/or SAS applications
  • Strong communication skills and comfortable speaking and presenting to leadership

Preferred Qualifications

  • Knowledge of additional external regulations, including 21 CFR Part 4, 21 CFR Part 11, ISO 14971, Medical Device Directive 93/42/EEC , Therapeutic Goods (Medical Devices) Regulations, MHLW Ministerial Ordinance No. 169, SOR/98-282, and RESOLUTION ­RDC  Nº 16
  • Experience with Post Market systems / processes
  • Experience with CAPA, Management Review / Controls, and External Audits
  • Flexible and positive attitude
  • Project management skills.

 

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

 

Requisition ID: 443322

 


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