Quality Assurance Specialist
An exciting opportunity has arisen for a skilled Quality Assurance Specialist to join our organization. This role is based in Cork and offers a permanent contract.
This position will be based onsite, Monday to Friday, with standard office working hours. The ideal candidate will have a junior-mid level profile of experience, ideally coming from a regulated, manufacturing environment.
* The Quality Assurance Specialist will drive and implement process improvements to ensure predictable processes across all product lines. This includes risk reduction, yield improvements, error proofing, cost reduction initiatives, and process automation activities.
* The Quality Assurance Specialist will provide effective and responsive quality support to operations to meet their area's objectives of quality, cost, and output.
* The Quality Assurance Specialist will ensure all process variables and their interactions are adequately defined. They will identify and address all failure modes in the process, using techniques such as DOE studies and FMEA's.
* The Quality Assurance Specialist will drive and implement plant-wide quality system improvements.
* They will ensure regulatory compliance in their area of responsibility, adhering to cGMP's of all medical device regulatory agencies, including FDA and TUV.
* The Quality Assurance Specialist will manage the Incoming Inspection area to ensure efficient supply to production areas.
* They will provide functional expertise to other support functions on quality-related issues, including regulatory requirements, statistical techniques, and sampling principles.
* The Quality Assurance Specialist will approve change requests for process and quality system changes.
* They will compile required regulatory documentation, including technical files, design dossiers, product transfer files, and essential requirements.
Requirements:
* Minimum of Bachelor of Science Degree in Engineering/Technology.
* 2-3 years' experience in a manufacturing environment or equivalent, with direct experience in a QA environment (preferably GMP regulated).
* Experience in the medical device industry is an advantage.