Novocure
  • Quality Assurance
  • Portsmouth, NH, USA
  • Salary
  • Full Time

Comprehensive Benefits Package


This position reports into the US Quality organization and is responsible for supporting Novocure's product testing. Primary responsibilities include development of test equipment requirements, project team participation, developing and conducting validations, and managing the US Equipment Program.  Additional responsibilities are 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 requirements for testing systems
Lead or participate in testing system development projects
Develop effective validation protocols and assure completed validations meet requirements, identify risks, and assure expected performance will be realized
Perform risk assessments and FMEAs, implement their resultant mitigations
Develop and update procedures required by the quality system as needed
Direct involvement with FDA inspections and third party 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
Other related duties as assigned

 

Qualifications:
Bachelor's degree in Electrical or Systems Engineering or equivalent and at least 2 years of engineering or quality engineering work experience required.
One plus year of experience in a FDA regulated or similar environment is required with QSR (21 CFR Part 820) experience preferred
Experience in a medical device manufacturing and/or product service environment preferred
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 have project management experience and 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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