Description
I currently have a fantastic permanent opening for a Quality Engineer with an innovative medical device company based in Dublin. This is an excellent opportunity to join a company at an exciting time for this rapidly growing company.This role will have responsibility for leading the design process for new and existing products. This involves managing and supporting various validation activities, assisting in safety & efficacy studies and guiding new products from validation through to launch.
This role will have responsibility for quality and regulatory elements required to support post launch activities of the company product portfolio.
Key Responsibilities:
Lead validation projects for new products and existing products, including process, cleaning, and computer system.
- Lead in design transfer process- bringing new products from validation to launch.
- Responsibility for the development and authorisation of comprehensive protocols for testing and analysing new products.
- Lead risk management activities as per regulatory requirements
- Assist the CTO with the preparation and execution of biocompatibility, preclinical and clinical assessments related to the evaluation of safety and efficacy of new products as required by regulatory authorities.
- Perform scale up activities for existing products
- Manage stability and sterilization schedules for products
- Prepare and document, risk assessments, protocols, test methods and Design History Files in accordance with current ISO and FDA Standards.
- Lead regulatory and quality projects as assigned by management.
- Manage and co-ordinate equipment calibration and PM schedule.
- Support Design and Development of new products (up to Class III), including prototype development, from concept generation to product launch.
- Quality support manufacturing processes including incoming inspections, quality in-process & batch reviews
- Write and complete NCs & CAPAs as required
- Perform internal audits as per FDA/EU and ISO requirements
- Perform vendor audits as per vendor audit plan incl material suppliers & distributors
- Assist with customer complaint and post market surveillance activities.
- Collaborate closely and effectively with cross-functional departments - Marketing, Regulatory, and Manufacturing to drive projects to completion within schedule.
- Provide technical leadership in the resolution of product and process quality issues, through the use of root cause analysis techniques and corrective/preventative action processes.
- Work collaboratively as a member of a dynamic team focussed on achieving excellence in product quality, customer service and achievement of company goals.
Experience Required:
- Bachelors degree or equivalent in a Science discipline
- Minimum of 3 years of hands-on Validation experience in the highly regulated medical device / medical diagnostic field.
- Product Development experience to current FDA and MDD design control requirements.
- Strong experience and knowledge of risk management activities
- Contemporary knowledge of relevant business processes and systems in the medical technologies industry, including new product introduction, quality systems, regulatory requirements (e.g. ISO 13485 and FDA 21 CFR 820), process validations and process capability.
- Strong technical, analytical, problem solving and decision making skills.
- Good personal organisation and project management skills.
- Excellent interpersonal and communications skills.
- Must be able to travel as required by the position.
- Internal and vendor audit experience an advantage
If you are interested in hearing more about this excellent opportunity apply directly to this advert or contact Derek Sheridan on for immediate consideration.