Working in our clients newly established laboratory located in their Dublin campus for biomaterial development in the medical devices market place, this is an excellent career opportunity for a Quality Engineer to join a dynamic and growing team in the development and commercialization of innovative biomaterial products across a variety of medical sectors.
In a strategically important role, the successful candidate will have extensive quality management experience in a related area (medical products ideally), capable of leading a multidisciplinary team through quality management procedures and training. This person will manage a team through ISO 13485 audits and will be responsible for ensuring the upkeep and maintenance of the QMS and associated documentation. The successful candidate will be capable of interfacing with senior management and should be flexible towards working across different areas of company development. This person will form a critical role within delivering product solutions which benefit our customers.
The successful candidate will be responsible for:
- Upkeep and maintenance of the Quality Management System within our client.
- Implementation of documents, training and strategies to ensure Quality levels meeting requirements of the ISO 13485 guideline standards.
- Working with R&D engineers on product development in terms of documentation and quality management.
- Working with a team to design and develop of 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.
- Management of a team, delegation of tasks, decision making, 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 monthly management reviews as management representative for quality within company.
- Leading a team through audits and regulatory navigation.
- An honours Bachelor's Degree in engineering/science or related discipline is required.
- A technical Master Degree or PhD in a related discipline is advised but if the candidate is experienced this will be equally considered.
- Project Management experience is required.
Length of experience
- A minimum of 5 years+ quality engineer in medical device design or related area is required.
Specialized skills/technical knowledge
? Quality Management & regulatory approval.
? Product Design Experience
? Ability to new documentation and train team to follow protocols.
? Medical Device Regulations
? Experience of working under medical device design controls, with proven knowledge of design verification/validation and design/process FMEAs.
? An advanced understanding of medical device quality systems, biomaterial safety and external regulatory requirements.
? Design for Manufacture
? Project Management and Team Participation
? Strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience.
? A demonstrated track-record of being part of successful cross-functional product development teams.
? Advanced problem solving, decision making and root cause analysis skills.
? Ability to effectively communicate concepts, ideas and knowledge to all relevant stakeholders. Works well as part of a team.
A competitive salary in the region of 50 - 60K/annum dependent on experience.