Co-op, QARA

Position Summary

Job Purpose
Support the Quality Management System of Teleflex Medical, INTL, Athlone.  Ensure Teleflex is positioned at all times as a key preferred supplier within the medical devices space.
 
Be responsible for ensuring activities associated with Quality Systems, Regulatory Affairs and Post Market Surveillance are approved, communicated, written and delivered as appropriate.  This will include the initiation and processing of document change orders, working with product registrations and customer complaints ensuring compliance to associated regulatory requirements and Teleflex processes and procedures.  
 
 

Principal Responsibilities

Key Responsibilities
 
Key responsibilities will include (but are not limited to) the following: 
 
Quality System compliance to ISO 13485, Medical Device Directive, ISO 9001 and 21 CFR Parts 820 & 11 

• Administrative support for Quality Systems including:

Review of Quality System (QS) documents for change
Prepare change order requests 
Process change order requests 
Maintain all relevant documents in line with change order process, including all relevant training documents

• Administrative support for Regulatory Affairs including:

Processing new product registration requests
Maintaining product registrations database
Technical File support 

• Administrative support for Post Market Surveillance including:

Processing customer complaints 
Building of FCA files (soft and hard copy) to audit standard
Support in preparation of management review reports

• Support other activities as required.

Education / Experience Requirements

Essential Skills / Experience
Excellent technical writing skills – essential
Attention to detail and accuracy – essential
Ability to work well under deadlines and pressure
Communication skills
Problem solving skills for developing creative solutions and meeting objectives.
Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel); 
Excellent analytical ability
The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.  
 

Specialized Skills / Other Requirements

Key Relationships / Interfaces
Senior Quality Systems Specialist
Senior Complaints Manager
Regulatory Affairs Manager, Athlone
VP of Global QA/RA
VP of QA
INTL QA/RA 
UK & INTL  Customer Service

Behaviors / Values
Approachable and enthusiastic. 
Flexible and adaptable. 
Able to work on own initiative and as a team player.
Good organizational skills with cultural awareness and sensitivity
Good judgment and problem-solving ability & is capable of understanding the impact of decision making on both Teleflex Medical and their customers.
 
Note:  As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities will evolve and change over time.