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Associate Lead - (Quality System) Job

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Date: Mar 2, 2019

Location: New Delhi, HR, IN

Company: Boston Scientific

Location: Gurgaon , Haryana (India)
Hiring Manager: Dipnaka Medhi
Recruiter: Nipun Anand



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.


About the role:

The R&D Quality System engineer will be a part of the R&D Quality organization. The individual will be responsible for sustaining and continually improving the site quality system, facilitating and conducting audits and coordinating the CAPA process. The individual must be self-driven as well as a team player who is willing to collaborate and work with different cross functional teams across geographies and cultures.


Your Resonsibilities will include:

  • Own, sustain and continually improve the site quality management system by executing the existing requirements and by driving improvement and simplification initiatives.
  • Drive and implement all the globally driven initiatives/changes at the site in the areas of Quality Management System, Audits (Internal and External), Document and Record Control and CAPA.
  • Collaborate with the extended global teams for participation in different global/site projects.
  • Represent the site in different global/regional communities of practice.
  • Facilitate the quarterly management reviews for the site along with the site management representative.
  • Facilitate external audits with the notified body.
  • Participate in quality planning for the site.
  • Lead and conduct internal audits for the site.
  • Guide and train users at the site for different quality management system related aspects.
  • Drive awareness sessions in the space of quality management system for the site as identified.
  • Lead the product data, product life cycle and document control activities and system for the site.
  • Support the site users for all document control activities.
  • Author and own all site documents in the space of Quality management system, Audits, Document and Record Control and CAPA.
  • Maintain records as per the site/organization’s record management process.
  • Coordinate NCs and CAPAs for the site.
  • Drive the Non-conformance and CAPA metrics and mentor record owners.
  • Facilitate CAPA review board meetings for the site.
  • Drive quality culture at the site through various trainings and other employee engagement activities.


What we're looking for in you :

  • Bachelors (or higher) degree in engineering or life sciences preferably in mechanical engineering, electronics and embedded systems, plastics and polymer engineering or biomedical engineering.
  • 8+ years of experience in medical device - in quality systems and / or quality assurance.  
  • Preference for candidates with PMP certification or similar project management training and experience.
  • Professional training and certification in in Quality Management Systems including ISO 13485, 21 CFR 820, and CAPA management.
  • Certification as an Internal Quality Auditor will be preferred.
  • Sound understanding of medical device regulatory requirements for Class II and III medical devices.
  • Proficient in MS Office.
  • Experienced in process based work culture.


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: 441381


Job Segment: Medical, CAPA, Engineer, Chemical Engineer, Healthcare, Quality, Management, Engineering