Senior Quality Engineer

Company Overview:

This is a Hybrid Perm Position based in Co. Limerick

Overview of Role:

• Lead key elements of quality system to ensure compliance to relevant standards for the business including EN IS013485 and FDA QSR.

• A primary function of this role is to lead and supervise the Manufacturing Quality group, consisting of Quality Technician(s) and Engineer(s). Agree objectives, generate training plans, coach team members, carry out performance appraisals and deal with performance related issues. Assess workload for the group and allocate tasks accordingly.

• The role will take the lead in ensuring that areas of the Manufacturing Quality are maintained and implemented in a compliant manner and areas of improvement are identified and implemented as required.

• Lead and direct the Manufacturing Quality support functions to ensure quality and regulatory compliance. This will involve coordinating and working with all functions in a collaborative manner where quality compliance is dependent.

Responsibilities & Duties: 

• Drive quality culture in accordance with companies quality policies, guidelines and processes

• Champion compliance to applicable Global Regulations and standards (eg. US FDA, 21 CFR 820, ISO and IVDR: In Vitro  Diagnostics Regulation)

• Collaborate with Quality Manager to ensure quality management system is maintained and continually improving

• Responsible for the Manufacturing Quality support function including approvals in the change control process                  and ongoing compliance, in conjunction with the appropriate resources.

• Generation of reports for data trending and analysis of the process (as required).

• Represent the team at key review meetings.

• Serve as a resource to NC/CAPA investigations for conducting root cause analysis and developing and implementing  corrective action plans.

• With the support of subject matter experts (SMEs), drive investigations, perform robust root cause analysis,

develop and implement corrective actions, and establish effectiveness monitoring plans

• Identify and implement opportunities for improvement.

• Maintain a proactive approach to developing the company’s system to meet the changing needs of the business.

• Ensure that in-house or external Quality issues are effectively prioritized and acted upon in a timely manner.

• Ensure compliance for manufactured and distributed products

• Provide advice and support to colleagues on quality matters

• Represent quality department in company projects where required

Essential Criteria:

• A minimum of a Bachelor’s degree (Hons) in Engineering, Technology, or Science. (Level 8).

• Proven knowledge and experience (ideally minimum 8 years) of working with ISO13485, ISO14971, the IVD /

IVDR: In Vitro Diagnostics Regulation and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11.

• Qualified Lead Auditor in ISO

• Excellent working knowledge of 21 CFR 820 and ISO 13485 standards

• Knowledge of CE IVD regulations

• Ability to manage competing priorities in a fast-paced environment

• Good leadership skills and ability to influence change

• Strict attention to detail

• Ability to interact professionally with all organisational levels

• Previous supervisory experience would be beneficial.

All applicants must be eligible to work in Ireland and hold a valid work visa as no sponsorship available for this position.

All Benefits will offered after a probationary period has been completed.