Job Title:
Quality Systems Manager
Location: Co.Mayo
Salary:
€70-95k per annum DOE
Role:
Onsite Full time
Summary:
Our medical device client in Mayo is searching for an Experienced Quality Systems Manager with specialised experience in Documentation, Inspection, Training and Receiving for Quality systems. The ideal candidate will hold quality auditing experience within a medical device industry whilst leveraging expertise in the manging the processes and procedures for regulatory approval.
Responsibilities:
- Adheres to all environmental, health and safety requirements, quality system procedures, and facility policies
- Leader in compliance to all necessary regulations
- Assesses conformance to documented procedures, regulatory, statutory, plant, divisional and corporate requirements
- Assists in the establishment and maintenance of the assessment process including scheduling, performing and generating audit reports
- Responsible for the management of the Internal Assessment Programme and the Documentation System
- Co-ordination of Audits by Regulatory Bodies and Contract Drug Companies
- Responsibility for the Supplier Quality Management programme which includes assessing and approving supplier quality systems, inspection of Suppliers for reduced inspection or certification
- Responsibility for ensuring that an effective quality system is in place and provides assistance to management in the development of quality management systems
- Responsibility for the management of the documentation, labelling and training departments. Responsible for the adherence to quality systems that involve the changes to procedures, labels and BOMs etc.
- Responsible for management of training in conjunction with area management for their respective areas.
- Responsible for the receiving and inspection and release of raw materials from 3rd party suppliers.
- Tracks the status of audit issues to help ensure that adequate actions are taken, documented and completed in a timely manner
- Maintains adequate documentation to demonstrate that assessments have been performed as scheduled
Requirements:
- Bachelor’s degree or equivalent related experience
- Certification from a Recognized Body (preferred)
- Three to five years of related experience required (preferably quality auditing experience within a medical device or other regulated industry)
- Excellent communication and writing skills
- Excellent interpersonal skills
- Good presentation skills
- Reasoning Ability
- The ability to exercise independent judgment and draw accurate conclusions based on available information
KSGalway
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