Quality Manager

Collins McNicholas Recruitment & HR Services Group; Leinster; On-site; EUR 60,000 - 80,000; Full time

Job summary

Collins McNicholas Recruitment & HR Services Group is seeking a Quality Manager for a state-of-the-art facility in Offaly. This role involves managing the quality team, developing quality management strategies, and ensuring compliance with stringent regulatory standards in the medical device sector.

The ideal candidate will have substantial experience in quality functions, particularly within regulated environments, and will be responsible for leading continuous improvement initiatives.

If interested, please reach out to David Smith or Gillian Nicholson.

Qualifications

• 5-8 years' experience in quality functions in regulated environments.
• 3 years' management experience leading a Quality Management System/team.
• Demonstrable experience in Continuous Improvement activities.

Responsibilities

• Manage and develop the quality team according to targets.
• Implement Quality Management strategy and plans.
• Maintain compliance with regulatory requirements (ISO, FDA).
• Drive continuous improvement initiatives for the quality system.

Skills

Continuous Improvement

Quality Management Systems

Regulatory Compliance

Team Leadership

Education

BS degree in Engineering/Science or relevant field

Master's Degree or equivalent coursework

Tools

ISO 13485

Six Sigma techniques

Job description

Overview

My client operates a state-of-the-art plant in Offaly that specializes in sterile barrier packaging and performance packaging solutions for the medical device, diagnostic, and pharmaceutical drug delivery industries. The facility supports crucial packaging needs—including design, prototyping, tooling, validation, lab services, and sealing equipment—tailored to the highly regulated healthcare sector.

Responsibilities

• Manage and develop the quality team against agreed targets and budgets according to company standards, policies and procedures.
• Develop and implement Quality Management strategy and plans, including resource, systems, timescales, financials, to support, contribute to, and integrate within, the organisation’s annual business plan and long-term strategy.
• Develop, sustain and continuously improve the QMS in accordance with Company procedures and regulatory requirements. (ISO 13485, FDA 21 CFR Part 820, GMP/GDP, Customer Codes of Practice)
• Identify and manage the Quality Budget, ensuring the reduction in risk from claims and all potential costs.
• Act as site Management Representative responsible for the planning and execution of Management Review activities, including tracking and closure of action items.
• Responsible for the timely processing and closure of customer feedback through the QMS Complaint process, escalating critical issues as appropriate.
• Drive robust timely and effective corrective and preventive action programs through the CAPA system ensuring the use of appropriate problem-solving tools.
• Develop and maintain internal audit program, lead and support third party audit.
• Ensure compliance to Change control requirements, leading collaboratively and driving documented and timely change control within QMS.
• Identify, develop, and report QMS trending, metrics and KPIs. Enabling the senior leadership team to have oversight of QMS effectiveness and input into the sites priorities and objectives.
• Drive continuous improvement (CI) initiatives to enhance the quality system and ensure compliance to Corporate policies and procedures.
• Promote a culture of Quality first, ensuring continued focus on the developing awareness and positive engagement of all employees towards the continued improvement of Quality.
• Play an active role in the execution of projects identified to drive quality systems effectiveness.
• Liaise with customers and suppliers (where impacting/affected by quality issues)
• Create programs improving efficiency and quality in day-to-day operations within the facility.
• Quality authority in disposition of quality related customer issues and material issues/defects.
• Develop and conduct effective training programs on related QA topics for both Quality and non-quality employees
• Support and deploy corporate office standardisation activities/procedures.
• Complies to all EHS requirements and ensures Quality team adheres to all EHS requirements and processes

Requirements

• BS degree in Engineering/Science or other relevant field; Prefer Master's Degree or equivalent additional coursework.
• 5-8 years’ experience in quality functions in Medical Device or other regulated manufacturing environment (biotech, pharma, military/space).
• 3 years’ management experience leading a Quality Management System/team within a manufacturing environment.
• Demonstrable experience in the use of Continuous Improvement activities e.g. Six Sigma techniques.
• Certified Quality Auditor; ASQ or ISO 13485 (preferred)
• Knowledge of regulatory requirements including ISO 14971, ISO 13485, and FDA Quality System Regulations

If this Quality Manager job in Offaly is of interest to you reach out to David Smith or Gillian Nicholson at Collins McNicholas Recruitment to learn more.