Quality Systems Specialist

Job Title – Quality Systems Specialist

Location - Franklin Lakes, NJ

Duration – 8+ Months Contract

Total Hours/week - 40.00
1st Shift

Description:

Some activities are listed below:
• Interface with other functions to ensure accurate and timely completion and review of documents.
• Collect and Analyze Quality Data to assist with Management Review content development, CER, PMS, Quality Scorecard, etc.
• Supports quality system improvement and standardization initiatives within MDS
• Support Post Market Surveillance (EU MDR, Canada, etc.) providing data and supporting the preparation of Post Market Surveillance reports and plans for submission to regulatory bodies.
• Conduct comprehensive literature searches, review of complaints, corrective and preventive actions, and MAUDE database and summarize in a report for medical devices.

Experience:
• Knowledge of US and International regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 13485, MDD, EU MDR, Canadian MDR, Japan PMDA as well as ANVISA and TGA requirements.
• In-depth understanding of the application of quality systems to the medical device industry.
• Experience with Trackwise and SAP
• Advanced proficiency in data analysis tools such as Excel, Qlikview and BI report preferred.

Support Post Market Surveillance (EU MDR, Canada, etc.) providing data and supporting the preparation of Post Market Surveillance reports and plans for submission to regulatory bodies.
Interface with other functions to ensure accurate and timely completion and review of documents.
Conduct comprehensive literature searches, review of complaints, corrective and preventive actions, and MAUDE database and summarize in a report for medical devices.
Collect and Analyze Quality Data to assist with Management Review content development, CER, PMS, Quality Scorecard, etc.
Supports quality system improvement and standardization initiatives within MDS