8 Quality Systems Specialist Jobs in Franklin, NJ
millenniumsoft is Hiring a Quality Systems Specialist Near Franklin, NJ
1st ShiftDescriptionSome 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.
- 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.
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
Job Summary
Contractor
IT Outsourcing & Consulting
$115k-141k (estimate)
06/05/2024
07/22/2024
gomillenniumsoft.com
FAIRFAX, VA
50 - 100
2000
SHAILAJA MASHETTY
$5M - $10M
IT Outsourcing & Consulting
Related Companies
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Quotes from people on Quality Systems Specialist job description and responsibilities
This position has primary responsibility for supporting and providing oversight of the Neuromodulation Quality Management System.
01/29/2022: Chicago, IL
Provide quality expertise and guidance to the site personnel on quality system policies and procedure
01/21/2022: Columbus, MS
Quality Assurance Specialist checks ensure the ongoing reliability of the manufacturing process and document your findings for management.
02/11/2022: Albany, GA
Responsible for Collecting quality metrics data related to corrective actions, complaints, operational changes, and process capability.
04/13/2022: Lincoln, NE
Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Quality Systems Specialist jobs
Quality Assurance Specialist roles examine the company's operations, assess areas where production efficiency can be improved
03/29/2022: Orange, CA
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