Integra LifeSciences

Quality System Coordinator

Vacancy ID
2017-23536
CH-NE-Le Locle
Position Type
Regular Full-Time
Category
Quality Assurance

Overview

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.  Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has nearly 4,000 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

 

Integra LifeSciences has entered into an acquisition agreement of Codman Neurosurgery.   This transformational acquisition creates compelling value for our shareholders, employees and patients, and enhances our global position in neurosurgery by adding a complementary product portfolio and the world-recognized Codman brand. This expansion position is open as a result of this exciting acquisition.

Responsibilities

SUMMARY DESCRIPTION


As the Quality System Coordinator on our site in Le Locle, Switzerland facility, you will be responsible for control and maintenance of all relevant quality system documentation, including standard operating procedures, work instructions, forms, and external standards.

 

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Responsible for supporting the maintenance of the document control system
  • Responsible for formatting, proper spelling and clarity of text for any written documents submitted to document control
  • Review electronic documents submitted to document control for correct formatting, spelling and clarity of text before releasing as approved documents
  • Maintains all ISO/FDA standard operating procedures, work instructions and forms
  • Maintains revision and approval status of all documents
  • Maintains official copies (either hard copy or electronic) of all approved documentation
  • Maintains appropriate form templates for access
  • Updates computerized documents with data from change control documents and maintains archive of changed ISO/FDA controlled documents
  • Manages circulation of documents for management approval
  • Act as contact point for Corporate for the issuance of new or revised corporate policies and procedures
  • Tracking, follow-up and implementation of, including but not limited to, ECOs, validation records
  • Responsible for supporting record retention activities (collection, shipment and retrieval to/from offsite storage)
  • Assist in management review and Quality Progress report preparation
  • Participates in quality system improvement initiatives
  • Assists with external audits, generating reports with corrective action plans and ensuring implementation of corrective actions in a timely fashion

Qualifications

DESIRED MINIMUM QUALIFICATIONS

 

  • Minimum of 1-2 years’ experience in document and promotional materials management using electronic document management systems or with manual systems using electronic document storage
  • Minimum of 1-2 years’ experience in a Quality Systems / Regulatory Compliance environment with a working knowledge preferably in the medical device, diagnostics or pharmaceutical industries. Familiarity with FDA regulations and ISO series of quality standards preferred
  • Capable of both written and verbal effective communication skills in English and in french including presentations as assigned
    Proficient in the Microsoft Office suite of products
  • Solid organizational and document management skills

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