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Quality Sys Eng - P4

Work mode:  Onsite
Onsite Location(s): 

Yokneam, IL

Additional Locations:  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - 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.

 

 

 

 

DQA Engineer

 

 

 

Main Duties:

  • Member of integrated product team (IPT)- responsible for supporting activities required to ensure quality of the design though compliance with design controls.
  • Lead proactive design assurance activities facilitating the development and release of high-quality products.
  • Review and approve product design document- in accordance with design controls standards and company’s policies. This includes but is not limited to design verification and design validation activities.
  • Parenting with R&D- ensures design control processes are maintained and continuously improved to ensure on-going compliance to all applicable regulation and standards.
  • Assure proper documentation and execution of design planning, inputs and outputs, design review, V&V, risk analysis and design change per company and regulatory requirements.
  • Support audits and compliance assessments of DHF and other program files to ensure quality and regulatory requirements are met.
  • Partnering with R&D, RA, Clinic affairs and BU, ensure that pre-release elements of risk management activities are properly conducted and included within the applicable risk management file.

 

 

 

Required Qualifications:

  • Bachelors’ degree in Life Science, Engineering field or second degree in fields of quality and statistics
  • Proven experience in quality systems (4- 5 years) and in medical device field (minimum 3 years).
  • Experience working in an FDA and ISO 13485 regulated environment.
  • Project management skills, strong communication, problem solving, and analytical skills are required.
  • Leadership skills without direct authority responsibility
  • Strong English capabilities.

 

Requisition ID: 577277

 

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!


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