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QA COMPLAINTS COORDINATOR - MEDICAL DEV
Company:LIFE SCIENCE RECRUITMENT |
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Job Reference Number |
14221541 |
Client ID: |
RI/ |
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Posted On: |
Nov 17 2009 |
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Location: |
GALWAY, WESTMEATH |
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Job Type: |
Permanent |
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Salary: |
35,000 - 45,000 |
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Benefits: |
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Profile
Our client seeks a candidate with experience in medical device CAPA, vigilance and complaints reporting, with a background in Quality Engineering to manage their complaint handling and follow-up process for EMEA.
Job Purpose
The successful candidate will act as the primary contact for surgical customers and sales representatives registering confidential complaints and/or product dissatisfaction. Receive, answer and document customer complaints, telephone or written, on all products and enter complaint information as required into an electronic complaint handling system and ensure our client is positioned at all times as a key preferred supplier within the medical devices space.
Key Responsibilities
Key responsibilities will include (but are not limited to) the following:
Manage the complaint handling process including:
Receive and log product complaints from a variety of sources.
Document and coordinate the investigation of product performance issues.
Coordinate and/or perform complaint investigation, ensure related follow-up activities and document investigation findings and results
- Provide support on failure evaluation of returned products.
- Follow up on outstanding evaluations to ensure timeliness and regulatory compliance.
- Under limited supervision draft responses to specific product complaint and vigilance report queries from Competent Authorities.
- Monitor customer complaints and provide immediate feedback to concerned personnel when critical issue is detected.
- Maintain complaint tracking system
- Prepare complaint trending reports
- attend/facilitate meetings to resolve Customer Complaints
- Ensure effective CAPA is taken to help prevent reoccurrence
Responsible for supporting field actions and other post market compliance issues as assigned.
Provide support for the risk management process and provision of complaint data to risk management groups.
Support other activities in the post-market surveillance system as it develops.
Essential Skills / Experience
Engineering/Science qualification with 2/3 years of working within complaints in a medical device environment.
2/3 years experience in vigilance reporting – essential
Excellent technical writing experience within a medical device environment – essential
Good knowledge of the Medical Device Directive.
Good working knowledge of the Quality System Regulations as they pertain to customer complaints.
Experience with bio-hazard management/contamination control preferred
Attention to detail and accuracy – essential
Ability to work well under deadlines and pressure
Problem solving skills for developing creative solutions and meeting objectives are required.
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.
For Immediate Consideration Please Apply Online Now
Or contact for further details:
Eamonn O’Raghallaigh on 01 6854848
Visit our website for more jobs: http://lifescience.ie
