Novocure
  • 26-Jan-2017 to 27-Mar-2017 (EST)
  • US Operations
  • Portsmouth, NH, USA
  • Salary
  • Full Time

Comprehensive benefits plan


This position is responsible for supporting Novocure's quality systems. This includes conducting internal and external audits, CAPA investigations, development and maintenance of SOPs, supporting the collection and analysis of quality metrics, supporting company expansion plans. Novocure is a rapidly growing business and responsibilities can grow with the company. Located in the Portsmouth, NH office, this position reports to the US Quality Manager.

 

Essential Duties and Responsibilities:

  • Develop and update procedures required by the quality system as needed
  • Direct involvement with FDA inspections and third party audits
  • Conduct internal and supplier audits
  • Investigate Corrective and Preventive Actions (CAPA) as required
  • Help develop, maintain, and analyze quality metrics and trends for the facility
  • Support product service and/or repair activities as needed
  • Support Documentation and Configuration Management tools and processes
  • Support training and related processes
  • Other related duties as assigned

 

Qualifications:

  • Bachelor's degree in Engineering, Engineering Technology or technical discipline and at least 5 years of quality systems or quality engineering work experience required.
  • 5 plus years of Quality Assurance and experience in a FDA regulated or similar environment is required with QSR (21 CFR Part 820) experience preferred
  • Experience performing quality inspections within a FDA or similar regulated environment preferred
  • Experience in a medical device manufacturing and/or product service environment preferred
  • Thorough understanding of cGMP, and ISO 13485
  • Capable of building consensus across functional areas
  • Capability and confidence to lead cross-functional teams
  • Determination to succeed in a complex and challenging environment
  • Proficient in Microsoft Office

 

Knowledge/Skills/Abilities:

  • Must have good written and oral communication skills
  • Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail
  • Knowledge of FDA and ISO standards for Medical Devices is a plus
  • Ability to multi-task, perform efficiently, and independently

 

Working Condition:

  • Open office environment
  • May be required to lift up to 30 pounds.

 

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Novocure
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