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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


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