Job Summary:
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.
Benefits:
- Company pension
- Private medical insurance
Work Location: In person
