Quality Manager

Quasar Medical | Medical Device Manufacturer; Galway; On-site; EUR 90,000 - 120,000; Full time

Job summary

Quasar Medical Ireland is seeking an experienced Quality Assurance/Quality Management System leader to develop, implement, and maintain QMS processes.

You will act as Management Representative, oversee internal audits, CAPA, supplier qualification, and regulatory compliance across ISO 13485, FDA 21 CFR Part 820, and related standards.

This role requires strong leadership, regulatory knowledge, and the ability to drive continuous improvement across manufacturing operations in Ireland.

Qualifications

• 5-10 years of progressive experience in quality assurance within medical device manufacturing or related industry.
• Strong management and leadership skills.
• Solid knowledge of ISO 13485, FDA 21 CFR Part 820, and/or Medical Device Directives.
• Demonstrated proficiency in engineering and quality tools (FMEA, DOE, SPC).
• Excellent technical writing and verbal communication skills.

Responsibilities

• Act as the Management Representative for the QMS.
• Ensure QMS processes and documentation meet ISO 13485, ISO 9001, and 21 CFR Part 820.
• Report on QMS performance and identify opportunities for improvement.
• Promote regulatory and customer awareness of requirements and compliance.
• Serve as liaison with customers and certification bodies for audits.
• Provide leadership on QA matters including quality systems, compliance, and material disposition.
• Plan and conduct internal quality audits to ensure compliance.
• Oversee CAPA, customer complaints, and feedback for timely resolution.
• Review and approve suppliers affecting product quality and support supplier qualification.
• Drive continuous improvement initiatives to enhance QMS effectiveness.

Skills

Leadership

Regulatory knowledge

Quality systems

Technical writing

Cross-functional collaboration

Tools

FMEA

DOE

SPC

Statistical analysis tools

Job description

Responsible for development, implementation, and maintenance of QMS aspects of the Quasar Medical Ireland.

Essential Duties and Responsibilities:

• Act as the Management Representative for the Quality Management System (QMS).
• Ensure the QMS processes and documentation are established, implemented, and maintained in compliance with ISO 13485, ISO 9001, and 21 CFR Part 820.
• Report on QMS performance and identify opportunities for continuous improvement.
• Promote awareness of regulatory and customer requirements across the organization and ensure compliance.
• Serve as the primary liaison with customers and certification bodies for external audits.
• Provide leadership and direction on all QA-related matters, including quality systems, compliance, and material disposition.
• Ensure management review meetings are conducted in accordance with regulatory requirements.
• Oversee control of documents and records related to products, manufacturing processes, and the QMS.
• Plan, manage, and conduct internal quality audits to ensure compliance with applicable standards and internal procedures.
• Handle and monitor CAPA, customer complaints, and feedback to ensure timely resolution and continuous improvement.
• Ensure Quality Control operations are effective and efficient.
• Review and approve suppliers of components, raw materials, products, and services impacting product quality, and support qualification of critical suppliers.
• Drive continuous improvement initiatives to enhance QMS effectiveness and compliance.
• Carry out supervisory responsibilities in accordance with company policies and applicable laws, including interviewing, hiring, training, performance management, and employee development.
• Plan, assign, and direct work; evaluate performance; recognize achievements; address employee concerns.
• Stop production or shipment in the event of product quality issues to prevent non-conforming products from reaching customers.

Education/Experience and Qualifications:

• 5-10 years of progressive experience in quality assurance and control within medical device manufacturing or a related industry, with in-depth knowledge of manufacturing processes and quality systems.
• Strong management and leadership skills.
• Solid knowledge of ISO 13485, FDA 21 CFR Part 820, and/or Medical Device Directives.
• Demonstrated proficiency in engineering and quality tools (e.g., FMEA, DOE, SPC, and statistical analysis tools).
• Ability to support product development, manufacturing, and product release activities as directed by senior management.
• Excellent technical writing and verbal communication skills.
• Ability to effectively collaborate with personnel at all levels of the organization.
• Willingness to travel as required for supplier assessments and other business activities.