Our client, a medical device company in Shannon are currently looking to recruit a Quality Compliance Lead
for their site.
The primary responsibility of this position is to lead the Quality compliance function to assure conformance to established requirements and standards for products and processes through the effective implementation of the Quality Management System processes. This will entail directing and/or supporting the Quality Management System processes, including but not limited to Corrective and Preventive Action, Internal and External Audits, Quality Trending, Quality Management Review and document and record control. Must interact with many different functional departments, suppliers,
Duties and Responsibilities:
- Manages the Quality compliance function and provides leadership and direction to the Quality Compliance team.
- Oversees effective implementation of the Quality Management System (QMS) throughout the organization, including leading gap assessment and closure for any regulatory changes that have impact on the quality management system and actively coaching the organization to support the effective implementation and maintenance of a QMS.
- Supporting Top Management in the development and implementation of quality systems strategies and objectives.
- Maintains the site Quality Manual and Quality Systems Procedures and ensure contents are aligned to the Global company process and applicable regulations/standards.
- Leads site CAPA program including, collecting and analysing data to appropriately and efficiently identify ‘Root Cause’ and ensuring ‘Verification of Effectiveness’ plans are comprehensive, to facilitate overall improvement in performance of key quality system elements,
- Manage and monitor quality trending process for determining the effectiveness of applicable quality systems, develop processes and plans to address improvements as identified.
- Leads site internal audit program, including conducting internal audits and ensuring that audits are completed on time and in full and that all observations are being addressed by owners as appropriate.
- Coordinates and supports effective management review process, ensuring all key quality performance trends are identified and dispositioned.
- Manages any 3rd party external audits and corporate audits through preparing the site; including managing the back room and supporting the front room.
- Manages the document control function to ensure all relevant QMS documentation is accessible and up to date following site change management process
- Bachelor’s degree in engineering is required or an alternative Bachelor’s degree with certification as a Quality Engineer (e.g. CQE)
- Must have minimum of 5 years of experience in Quality Engineering field
- Must have previously worked in a highly regulated industry, preferably Medical devices or Pharma.
- Must be familiar with all aspects and elements of a quality system including but not limited to management responsibility, resource management, product realization and measurement, analysis and improvement processes.
- Strong knowledge and Clear Understanding of 21 CFR 820, ISO 13485 and regulatory requirements applicable to the QMS.
- Qualified Lead Auditor to 21 CFR 820 or ISO 13485/9001 (IRCA Accredited Lead Auditor qualification desirable).
- Demonstrated technical expertise
- Demonstrates ownership for the integrity of work
- Able to work independently and within a team, and consider options for completing work
- Ability to deliver, meet deadlines and have results orientation.
- Strong written and verbal communication skills, with ability to communicate to multiple levels of the company.
- Previous experience in directly or indirectly managing a small team
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