An excellent career opportunity for an ambitious Quality Assurance Manager to join a dynamic and fast growing team in the development and commercialisation of innovative products.
The QA Manager will have extensive quality management experience in a related area (medical products/materials ideally to ISO 13485 or ICHQ7 standards), capable of leading a multidisciplinary team through quality management procedures and training.
Experience working with clean room systems would be an advantage while relevant quality management system experience (ISO 13485 or ICHQ7 or relevant other stringent systems) would be essential.
The QA Manager will manage a team through ISO 13485 audits and will be responsible for ensuring the upkeep and maintenance of the Quality Management System (QMS) and associated documentation. The QA Manager will be capable of interacting with senior management and should be flexible towards working across different areas of company development.
Fulfilling the role of management representative including:
- Representing on company visits and audits
- Ensuring that processes needed for the quality management system are established, implemented and maintained
- Reporting to top management on the performance of the quality management system and any need for improvement
- Ensuring the promotion of awareness of regulatory and customer requirements throughout the organisation.
Implementation of documents, training, and strategies to ensure Quality levels meeting requirements of the ISO 13485 guideline standards.
Management and delegation over activities in sub-teams including completion of tasks towards quality improvement.
Working with R&D engineers on product development including overlap in design and development activities, documentation and quality management.
Some overlap working with the team to design and develop new innovative products, including concept development, high-level design feasibility, prototype development, detailed design, test method development, design verification/validation, shelf-life determination and product commercialisation.
Project management of a team, delegation of tasks, decision-making, and company representation in quality related areas.
Preparation of technical documentation in accordance with regulatory and design control requirements and with the company's development processes.
Conducting regular management reviews as management representative for quality within the company.
Management of CAPA's/NCRS
Lead audit representative in company visits.
Leading the team through audits and navigating regulatory requirements.
- An honour Bachelor's Degree in engineering/science or related discipline is required.
- A technical Master Degree or Ph.D. in a related discipline is advantageous but not compulsory.
- Previous Quality Management Experience in a relevant area is required.
- Certified auditor qualification (e.g. IRCA Lead Auditor) would be advantageous.
- A minimum of 5 years+ quality engineer in a medical device design environment or related area is required.
For further information on this QA Manager Medical Devices position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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