Quality Assurance Specialist

JOB SUMMARY:

The Quality Assurance Specialist supports Novocure's product development activities by tracking project commitments and ensuring quality system requirements have been met. This position involves frequent communication and coordination with engineering and quality team members in Portsmouth NH, Switzerland, and Israel.

This is a full-time, exempt position located in our Portsmouth, NH facility, but can be worked remote and reporting to the Lead QA Specialist; must be located in EST (Eestern Standard Time).

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Review product development documents and procedures to ensure they meet Novocure quality system requirements consistent with applicable regulations, standards, and guidance
• Contribute to the creation of project quality plans and reports, and design history files
• Participate in and provide compliance guidance for product development design reviews
• Provide advice, guidance, and training as needed to ensure product realization activities and documentation meet quality system process requirements
• Provide constructive feedback to improve project documentation
• Participate in corrective and preventative action activities
• Provide support as needed to the product development quality team, including procedure creation, tracking of documents or other activities, etc.
• Any other duties as assigned

QUALIFICATIONS/KNOWLEDGE:

• Postsecondary education and at least 3 years of experience in medical device product development or other regulated industry
• Demonstrated technical writing skills
• English language mastery and fluency
• Critical thinking and decision making, including the ability to recognize when to ask questions
• Good written and oral communication skills
• Highly organized and strong attention to detail
• Familiarity with Quality System Regulation, Medical Device Directive / Medical Device Regulation, ISO 13485, and ISO 14971
• Able to work in a team environment and execute responsibilities with minimal direct supervision

OTHER:

• Ability to lift up to 20 pounds

Novocure is taking a responsible approach to creating environments that allow us to strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.

As part of our commitment to health and safety, COVID-19 vaccines are required for our current U.S. employees. As an Equal Opportunity Employer it is our policy to provide reasonable accommodations to any qualified individual, who, because of a medical condition, or sincerely held religious belief/practice, receives an exemption from the vaccination requirement, if such accommodation would not result in an undue hardship for the company.

For more information regarding the Novocure's COVID-19 vaccination requirement, exemptions, and verification of vaccination status please ask the Talent Acquisition Team.

ABOUT NOVOCURE:

Our vision

Patient-forward: aspiring to make a difference in cancer.

Our patient-forward mission

Together with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.

Our patient-forward values

- innovation

- focus

- drive

- courage

- trust

- empathy

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