Job Description

• Assist Regulatory Affairs to implement and maintain the company’s quality management system according to ISO 13485 (2016) and other applicable regulatory requirements
• Take ownership of and maintain the company’s ISO documentation system
• Gain familiarity with manufacturing processes, then monitor these processes from a Quality standpoint.
• Take control of and monitor Device History Record (DHR) documentation
• Review and sign off DHRs and other documents from a QA perspective for accuracy and completion.
• Monitor and sustain the quality and integrity of all product manufactured at BIOVIC
• Review and sign off QA release forms for all commercial product
• Train employees on GMP and audits as necessary
• Coordinate and maintain the CAPA and NCR systems for the company

Job Requirements

Candidate must have at a minimum a bachelor’s degree in a relevant subject area, such as science or engineering.

At least 4 years’ work experience in the QA field is required

Must have experience and familiarity with ISO 13485 Quality Systems

Medical device and cleanroom familiarity is preferred

Experience with internal and external audits is required

Familiarity with basic statistics and software is a plus.

The company has customers all over the world, as such excellent English speaking, comprehension and writing skills are required.

Skills