Supplier Quality Engineer, Life Sciences
2 weeks ago
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.This role offers an individual the opportunity to be part of the Access Solutions Product Performance team within the Post Market Quality Assurance team at Boston Scientific.
The primary activity for this role is to lead and support post market quality assurance activities related to Boston Scientific products.
This position is a vital part of improving patient care by monitoring Boston Scientific devices to ensure they are performing safely and effectively.
Provide Quality Engineering support for the Post Market Design Assurance team.Collaborate with engineering, clinical and other functions to ensure quality requirements are met.
Provide quality and compliance input to project teams for project decisions and deliverables, especially those related to risk.
Partnering with team members (and cross-functional teams) to ensure the development and execution of streamlined robust solutions to post-market quality processes are effectively implemented.
Attend communities of practice for Post Market Surveillance and provide training to affected members of the organization when new or updated quality system requirements are released.
Draft and review post market surveillance and post market clinical follow-up reports.Prepare and present post market data and recommendations to cross-functional groups.
Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Adhere to all requirements of the Quality Management System.Comply with the Health & Safety policies of the company and inform Management of unsafe working conditions.
4-5 years of medical device experience, or advanced degree with a minimum of 3 years medical device experience.
~ A strong understanding of post market surveillance activities including post market clinical follow-up.
~ Experience working in a quality role at a medical device company.
Experience with post-market surveillance, including cybersecurity.
Experience with post market clinical follow-up and other clinical risk activities.
Experience working with PLM (Windchill) and ERP (MES and/or SAP) software.
Experience with quality system integration.
Experience with risk remediation projects.
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
Senior Quality Engineer, Medical Device Engineer, Quality Engineer, Quality Assurance, QA, Engineering, Technology, Quality
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