Location:

Dublin

Qualifications:

Degree

Experience:

3-4 Years

Job Type:

Permanent

Salary:

Negotiable

Consultant:

James Cassidy 01-6854545

Quality Assurance Specialist

Quality Assurance Specialist

Reporting to: Quality Manager

Primary Job Function:
The Quality Assurance Specialist is responsible for the review, approval and processing of document change requests, assisting in the development and maintenance of the quality management system, acting as Lead Auditor, developing quality KPIs and supporting the complaint handling process.
Core Job Responsibilities:
Responsible for compliance with applicable Corporate and Divisional policies and procedure

• Ensuring that area procedures as well as operational area procedures are correct and updated as necessary.
• Review of document change requests to evaluate each change for quality related issues.
• LIMS administrator for QA function.
• Assist in the development and maintenance of the quality system as required, ensuring compliance to ISO13485:2003.
• Provide guidance to Technical Service and Customer Service on quality system issues.
• Contribute to making the operation efficient and compliant by effective liaison with all departments in quality matters.
• Facilitate internal audits of the systems and processes on a regular basis as performed by the internal audit team. Act as Lead Auditor.
• Participate and report at management review and assist in resolving issues that may arise.
• Conduct QMS training for all employees.
• Participate in the development of the department KPIs. Assist in the preparation of internal statistical reports (KPIs).
• Schedule, chair and report at routine quality focused meetings influencing change and developing best practices.
• Function as QA support in handling Corrective and Preventive Action requests in the internal eCAPA system.
• Liaise with external groups in relation to complaint handling systems i.e. complaint investigation centres and complaint management centres

Education
Primary degree in Science, Engineering or Healthcare

Experience
• At least 2-3 years medical device/pharmaceutical and/or medical device manufacturing experience including practical working knowledge of the MDD, Risk Management ISO 14971, ISO 13485:2003, and FDA QSR 21 CFR Part 820 is desirable.
• Strong experience in dealing with CAPAs, leading investigations into non-conformances and leading audits.
• Ability to handle multiple tasks accurately and prioritize effectively.
• Interacts and communicates well with peers and colleagues.
• Responds to customer needs effectively and promptly.

For Immediate Consideration Please Apply online Now or Contact James Cassidy on 01-6854545