Jobs

Quality Manager

• Very competitive salary
• South East of Ireland
• 39 hours per week
• Pension
• Accommodation available
• ISO13485 & CFR part 820

We are currently recruiting for an experienced Quality Manager for our Medical Device Manufacturing client located in the South East of Ireland. The successful Quality Manager ensure that the product or service the organisation provides is fit for purpose, is consistent and meets both external and internal requirements You will naturally be involved with supporting and at times leading the company through it's FDA approval, so experience and a background in this will be highly advantageous.

Quality Manager oversees:

• Quality Assurance
• Quality management system
• Validation
• Regulatory
• Quality control

The Job Role
Quality

• Remain up to date with ISO requirements and ensure company is audit ready
• Support Company in transition to FDA compliance
• Quality system development, implementation & maintenance
• Ensuring that processes meet with ISO and AS requirements.
• Assessing product specifications and customer requirements and ensuring that are met.
• Agreeing in-house standards for quality
• Monitoring performance by gathering data and producing reports.
• Planning and Supervising the program of internal auditing
• Development, Maintenance and Approval of Standards
• Managing quality issues to ensure timely and effective corrective actions to prevent re-occurrence
• Providing support to Regulatory and Customer audits
• Monitoring the ongoing performance and outputs of the quality process and providing updates to managers and directors around quality issues.
• Supplier and Customer Liaison on Quality Issues.
• Provide validation expertise to maintain validated status for the facility.
• Oversee the design and execution of commissioning and validation protocols on manufacturing equipment, software and process, and approve validation documentation.
• Maintain an understanding of cGMP regulations and guidance in relation to all aspects of qualification of process and equipment. Coordinate validation team activities to ensure schedule adherence and compliance.
• Using statistical analysis, measure, control and improve on product and process robustness.
• Lead and develop team
• Conduct Performance reviews, RTW, probation reviews etc
• Hire/interview as needed. (Operation manager have input)
• Discipline as required in line with current procedures

Experience and skills:
Demonstrable experience in a similar role (QM, Validation management with FDA approval)

ISO 9001-13485 CFR 820 Knowledge essential
GMP (good manufacturing practice) experience
5why, 5s, NCR, CAPA

We will endeavour to respond to all applicants, but if you do not receive a response within 5 working days, please consider yourself unsuccessful on this application.
Syntech Recruitment Limited is acting as an Employment agency in relation to this position.
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