Quality Systems Specialist

Position Summary

The Quality Systems Specialist will provide professional Quality System Document Control service by processing and maintaining written documents and drawings in accordance with internal procedures and external regulations/standards (ISO 13485, 21 CFR 820, EU MDR and any other regulatory requirements applicable).  Provide guidance and assign training to Teleflex personnel.  Participate in Quality System related projects as required.  Coordinate and manage records management activities for Teleflex.

Principal Responsibilities

• Document Control: Assess, process, and maintain written Quality System documents and drawings in an electronic system.
• Perform Quality Systems Specialist / Change Analyst duties in an electronic documentation management system as needed.
• Review proposed changes, change notes and approvals; edit spelling, grammar and formatting.
• Prepare and process change orders.
• Prepare and process biennial reviews and provide instructions and reminder reports to document owners.
• Maintain databases/indices, distribution, and retrieval systems.
• Assign and track document and other control numbers.
• Assist with document control tracking and metrics.
• Issue periodic status reports (e.g. Overdue Reviews, Issued Documents).
• Training: Assess, process, and maintain Quality System training through an electronic learning management system.
• Process training requests.
• Update and maintain training in an electronic learning management system.
• Provide guidance on training assignments in an electronic learning management system.
• Assist with Quality System training and tracking.
• Participate in Document Control and records retention/storage related activities and projects as required
• Assist with Quality System related document control and training projects as required.

Education / Experience Requirements

• English proficiency is a must (B2 level and above)
• 2-year degree preferred; 2-3 years’ experience in the medical device industry including knowledge of FDA and ISO and other related industry regulations highly desired
• Experience in working with electronic document management system Agile desired
• Experience in working with electronic training system ComplianceWire desired
• Experience working in Quality Systems desired

Specialized Skills / Other Requirements

• Computer literate, (advanced word processing skills; competent in power point, spreadsheet and database applications; comfortable in networked environment).
• Strong proofreading skills.
• Attention to detail and accuracy is essential; good documentation practices.
• Service oriented.
• Able to communicate diplomatically and effectively (both verbally and in writing).
• Able to prioritize projects and adapt to shifting priorities.
• Able to clearly provide feedback to department management.
• Self-driven with the ability to work independently and/or as a team player.