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

Comprehensive Benefits Package


This position is responsible for supporting Novocure's quality inspection activities in the Portsmouth, NH facility. This includes conducting inspection acceptance activities, form reviews (document inspections), and some operational activities as needed.

 

Essential Duties and Responsibilities:

Responsible for acceptance activities for all products and components.  Signs off to releasing medical products for use by Novocure customers.
Inspect incoming, in-process, finished products for conformance to standards.
Identify non-conforming materials and initiate NCMR's.
Review completed records to ensure accuracy and conformance to Good Documentation Practices (GDP's).
Accurately document incoming, in-process, and final inspection data for trending.
Work with other personnel to resolve discrepancies.
Assist with operational processes, such as labeling, packaging, product cleaning, and shipping, as needed.
 

Qualifications:

HS Diploma
2 plus years of Quality Control Inspection experience, preferably in an ISO 9001, ISO 13485, and/or FDA regulated environment Knowledge of medical device quality system requirements (21CFR Part 820, ISO 13485) highly desirable.
Proficient in Microsoft Office applications
Experience working in computer systems (e.g., databases)
 

Knowledge/Skills/Abilities:

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

Working Condition:

Standing and sitting for extended periods
Lifting up to 30 pounds
 

 

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Novocure
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