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Job: Quality Systems Management Specialist, Contego Medical, Raleigh, NC

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General Information


Job title: Quality Systems Management Specialist
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Job location: Raleigh, NC  27607 United States
Requisition code:
Date posted: 03/08/2018
Job category:Manufacturing and Production
Quality Assurance
Documentation & Technical Writing
Employment type:Full time
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Job Description

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Contego Medical is currently recruiting a Quality Systems Management Specialist to join their growing team. This position will be updating and maintaining procedures, training records and under general supervision of the VP of Quality and Clinical Affairs, this person is responsible for daily management of the Quality System.

Position Requirements
Coordinates all activities related to Quality System. Assists in the creation and implementation of policies and procedures of Quality Management System. Requires working experience of quality systems, including, document and change control and understanding of corresponding regulatory requirements per FDA's QSR and ISO 13485 regulations. It also requires the ability to work with various functions in the company to ensure compliance to document control and change control procedures as part of Contego's Quality Management System. This position reports to the Vice President, Quality and Clinical Affairs.

Key Responsibilities
- Maintain an effective Quality System
- Plans, coordinates, and leads QA program associated with the creation and maintenance of GMP-related documents to ensure consistency with established standards
- Maintains an effective document control system, including routing, review, organizing, filing, and maintaining QMS documents (SOPs, WIs, Forms, etc.) and records and ensures change control compliance with FDA's QSR and ISO 13485
- Manages company-wide training program including the coordination of training activities, review, filing, and monitoring company-wide training status.
- Maintains Audit and Supplier Management Program
- Manages CAPA process, support root cause analysis and implementation of corrective action
- Assists in Complaint investigations
- Other tasks as required or assigned by management

The job responsibilities above are not comprehensive or exhaustive. The Company reserves the right to adjust, add to or eliminate any aspect of the above description. The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.
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Job Requirements

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- Minimum undergraduate degree in related field
- 5+ years' experience in Medical Device Industry
- Demonstrated understanding of ISO 13485, ISO 14971, and 21 CFR 820
- Well-developed teamwork and collaboration skills and the ability to communicate clearly and professionally both verbally and in writing.
- Ability to analyze, understand and effectively communicate QSR/QMS material and scientific/technical writing.
- Must have prior experience in document control in a regulated work environment.
- Ability to organize and set priorities in a fast-paced environment and work independently with minimal supervision.
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