Quality Manager

Harmonics Recruitment; Shannon; On-site; EUR 70,000 - 100,000; Full time

Job summary

Harmonics Recruitment's client, a recognised leader in precision engineering and medical device manufacturing, seeks a Quality Leader to guide the Quality function and ensure site compliance with QSR, FDA, ISO, and business plans.

Reporting to the Quality Director, you will provide technical leadership, lead internal audits, CAPA actions, and drive continuous improvement using Minitab and data-driven decision-making.

Qualifications

• Bachelor's degree in a scientific discipline (advantage).
• Minimum 5 years of quality management experience in medical devices or FDA-regulated environments.
• 3–5 years of people leadership experience; Lead Auditor certification preferred.

Responsibilities

• Ensure QSR/ISO compliance and act as management representative.
• Lead internal audits and CAPA processes; drive corrective actions.
• Drive quality improvements via Lean initiatives and data analytics.
• Interpret engineering drawings; support measurement/inspection processes.
• Prepare daily management reports and identify improvement opportunities.

Skills

Regulatory & Quality Systems

Statistical & Analytical Skills

Quality Assurance Leadership

Education

Bachelor's degree in a scientific discipline

Tools

Minitab

Job description

Join our client, a recognised leader in the precision engineering and medical device manufacturing industry. In this role, you will be part of a dynamic, forward-thinking team dedicated to delivering world-class quality, compliance, and innovation.

Reporting to: Quality Director

Job Purpose: To provide technical guidance, structure, and leadership for the Quality function, ensuring that the site meets and exceeds the business and quality plans.

Responsibilities:

• Ensure compliance of quality systems with the QSR and all current pertinent regulations. (e.g. FDA, ISO). Act as a management representative for the standards in place within the company.
• Promote the awareness of applicable regulatory requirements and quality management system requirements throughout the company to drive improvements to overall quality and compliance.
• Participation, co-ordination and maintenance of the internal audit process.
• Identifying and analysing non-conformances and related trends. Ensuring issues are highlighted and escalated to Senior Management for corrective and preventive action facilitating business improvement.
• Promote awareness of customer requirements within the company.
• Support the training management process.
• Lead the implementation of Quality improvement projects.
• Contribute to Lean initiatives within the Quality function and across broader business operations.
• Technical Leadership.
• Participate in the interpretation of Engineering drawings.
• Provide support to the measurement system analysis process.
• Provide support to the inspection process and participate in the review of inspection reports.
• Provide support with the preventive maintenance and calibration systems.
• Provide support to the scrap analysis process.
• Participate in ongoing problem solving and on corrective action teams.
• Review and approve CAPA actions in conjunction with Quality Systems.
• Utilise Minitab and other statistical tools to perform root cause analysis, process capability studies, and data-driven decision-making.
• Lead statistical analysis initiatives to identify trends, reduce variability, and improve product and process quality.
• Participate in producing daily management reports with a view to identifying and making recommendations on improvement opportunities.

Experience:

• Bachelors degree in a scientific discipline is an advantage.
• Advantage of having a minimum 5 years of quality management experience or equivalent in the medical device industry and/or FDA regulated environment.
• Must have experience in people leadership role (at least 3 to 5 years).
• Demonstrated knowledge of Quality Assurance.
• Excellent communication skills, including the ability to communicate to all levels of an organization.
• Excellent analytical and problem-solving skills.
• Demonstrated ability to collaborate with cross functional teams to ensure business success and ensuring compliance.
• Strong leadership skills, including influencing and team development.
• Thorough knowledge of QSR and ISO quality system requirements.
• Lead Auditor certification.
• Solid experience in medical device operations with a strong background in QA along with excellent communications and people management.

Skills:
Regulatory & Quality Systems Expertise, Statistical & Analytical Skills, Quality Assurance Leadership in Medical Devices