Quality System Manager - Medical Devices
Location : Passaic NJ US 07055
Job Type : Direct
Reference Code : 19034-BZ
Compensation : 65000.00 - 75000.00 USD/YEAR
Hours : Full Time
Required Years of Experience : 4
Required Education : BS Science or Engineering
Travel : No
Relocation : No
Job Industry : Medical Devices
Job Description :
- Permanent position for a Quality System Manager to drive improvements in the quality system, ensuring compliance with policies, procedures and standards for medical device manufacturing.
- Gathers data and information, including audit findings, customer complaints, and customer surveys, necessary to assess the performance and trends indicating the effectiveness of the QMS.
- Analyzes key metrics for trends indicating effectiveness of the QMS and identifies areas for improvement.
- Promotes and audits self-improvement efforts for quality management systems.
- Supports systems required to maintain external registration such as ISO-13485, and and FDA 21 CFR 806, 21 CFR 820.
- Supports global activities related to the internal audits, customer audits and third party audits
- Supports and ensures the Customer, Corrective Action, and Preventive Action processes are followed per the Quality Management System
- Develops and administers quality system training for proposed improvement activities.
- Supports new certification initiatives.
- Supports the supplier quality program.
- Fulfill role of management representative for company's QMS.
- Develops material for and participates in Management Review Meetings.
- Assists process owners with corrective/preventive actions.
- Supports unique device identifier (UTI) compliance activities.
- Overseas Data Quality Initiatives.
- Reviews reports of customer complaints and assesses them for MDR/MDV report an ability to FDA/competent authorities.
- Able to travel as required.
Required Qualifications :
- BS in Science or Engineering
- Minimum 4 years of experience in operations and continuous improvement in an FDA regulated industry (Medical Devices preferred).
- Working knowledge of FDA 21 CFR 820 (Medical device standard) and 806 (Device recall process).
- Management Representative experience (ISO 13485 preferred).
- Internal Auditing experience (provide training certificate).
- Sound understanding of GMP's and of quality systems, manufacturing systems, computer based management systems, ISO standards and application of FDA regulations for applicable products, processes, procedures.
- Experience with technical report writing required.
- Computer experience with Microsoft products and the ability to develop reports, spreadsheets, databases and presentations required.
- Ability to read and interpret engineering schematics/drawings/prints
- Minimum of one year experience conducting audits (certification a plus).
- Experience in MDR/MDV reporting.
Contact: Bill Zukowsky