Job description

Summary:
The quality assurance specialist is actively responsible for supporting the Quality Assurance department within defined company policies, procedures, and regulatory requirements. He/she must be able to ensure work is complaint to established procedures and policies. The position will also be responsible for creating and maintaining Post-Market Surveillance Plans and Reports per the In Vitro Diagnostic Regulation (IVDR) 2017/746. Duties will include:

• Create and maintain up-to-date Post-Market Surveillance Reports in accordance with recognized standards and applicable country-specific regulations.
• Ensure that document development and maintenance is conducted with the FDA Quality System Regulations and international standards.
• Perform statistical and trend analysis of raw data from post-market feedback.
• Conduct research of competitor products on market.
• Develop complaint rates and PPM (parts per million).
• Literature research of published data available pertaining to Company products.
• Carries out other duties as assigned in compliance with established business policies.

This is a temporary, full-time position hiring immediately and lasting indefinitely, with a schedule of Monday through Friday 8 a.m. to 5 p.m. Pay is $15 per hour.

Qualifications:

• Project management, multi-tasking, and excellent prioritization skills required.
• The ability to communicate effectively with all levels of employees throughout the organization.
• Good verbal and written communication skills, especially technical report writing, proficient in MS Word and Excel.
• Demonstrated ability to work effectively on project teams required.
• High school diploma required, Bachelor or Associates degree preferred.

Job Types: Full-time, Temporary

Pay: $15.00 per hour

Schedule:

• Monday to Friday
• No weekends

Work Location: One location

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