Our client a well funded start up based here in Galway are looking to hire a Quality Manager as they continue to expand operations.
The Role:
As the Quality Manager, you will play a pivotal role in establishing and maintaining a robust Quality Management System (QMS) in compliance with EN ISO13485:2016, EU MDR and 21 CFR Part 820 regulations. You will oversee various quality assurance and regulatory activities, ensuring adherence to organisational and external requirements throughout the product lifecycle.
Responsibilities:
- Lead the development and maintenance of the Quality Management System (QMS) according to EN ISO13485:2016, EU MDR and 21 CFR Part 820.
- Manage non-conformance and Corrective and Preventive Action (CAPA) processes, including containment, root cause analysis, and product disposition.
- Drive improvements to the quality system that ensures its suitability, adequacy, and effectiveness.
- Management of Design History File (DHF) and Device Master Record (DMR) in accordance with US and European regulatory requirements.
- Provide design assurance oversight and active participant in all stages of design development, testing and design control activities, ensuring quality assurance considerations and requirements met.
- Provide support to R&D, clinical, and manufacturing development activities.
- Ensure compliance with all organisational and external regulatory requirements.
- Plan, execute, report, and follow-up on subcontractor and supplier audits.
- Document and implement design and process validations in accordance with industry standards.
- Collaborate with other departments to streamline product approval and manufacturing processes.
- Facilitate supplier correspondence for key projects and drive quality improvements.
- Provide QA support in the review and approval of plant related validation protocols, reports, and change requests
- Oversight and responsibility to ensure site maintains adherence to Quality KPIs performance indicators
- Develop and implement continuous improvement programs in collaboration with Operations and R&D functions.
- Act as the lead complaint coordinator and oversee complaint handling processes.
- Provide technical support to project teams during process development, transfer, validations, and product commercialisation.
Requirements:
- Bachelor's degree in an engineering discipline.
- Minimum of 5-7 years of experience in quality management within the medical device industry.
- Ability to lead the quality team and drive a culture of quality within the organisation
- Strong knowledge of EN ISO13485:2016 and 21 CFR Part 820 regulations.
- Proven track record in managing non-conformances, CAPA, and root cause analysis.
- Experience in supplier management, auditing, and quality systems implementation.
- Excellent communication and interpersonal skills; ability to collaborate effectively across departments.
- Strong problem-solving skills with a proactive approach to quality improvement.
- Detail-oriented with a focus on documentation and compliance.
- Ability to thrive in a fast-paced, dynamic startup environment.
Desirable:
- Experience with the preparation of FDA, CE, Ethical Committee, and Competent Authority file submissions.
- Experience with event reporting during clinical trials.
- Entrepreneurial spirit with a positive can do attitude.
Benefits:
- Competitive salary and benefits package
- Flexible and Hybrid working solutions
- New office fit out with modern and well-appointed offices
- Opportunity to work in a well-funded scaling Start up
- Opportunity to work with a passionate team in a cutting-edge field.
For more information and a confidential discussion on the role please contact Michelle Mc Inerney.
michelle.mcinerney@collinsmcnicholas.ie
091 706717