Overview
Quality Specialist Jobs in Shannon, County Clare, Ireland at Mason Alexander
Title: Quality Specialist
Company: Mason Alexander
Location: Shannon, County Clare, Ireland
A cutting-edge leading Medtech company in Shannon, Co. Clare are looking got hire a Quality Systems Specialist to support the development and implementation of the Quality Management System in order to maintain 2017/745(MDR), ISO 13485, ISO 9001 and FDA QSR standards and requirements. The QMS includes medical device design and Development Manufacture and secondary packaging and distribution of medical devices. The ideal candidate will have experience working in a fast-paced, dynamic environment. Experience in start-ups & SMEs an advantage
Role and Responsibilities
Following, fostering and implementing a quality culture and other company manufacturing standards, policies and procedures
Ensure the effective implementation and maintenance of the Quality Management System.
Change Controls, CAPAs and Non-Conformance documentation, documentation control, employee training, design & development controls.
Investigating and troubleshooting problems, determine solutions or recommendations for changes and/or improvements, utilize tools such as root cause analysis.
Drive continuous improvement initiatives based on quality objectives.
Perform QA Verification of activities performed in production.
Review and update Quality System documentation (procedures, reports) as required.
Participate in preparation for and execution of internal & external audits from customers, Notified Bodies, Competent Authorities.
Generate reports as required and assist in any other data compilation as required.
Leading qualification & validation activities, such as equipment, processes, test methods, software.
Review & approval of Batch Records/ Device History Records.
Qualifications
Third level qualification in natural sciences (Certificate, Diploma, Degree level)
Previous experience in a highly regulated environment (pharma, food, med devices)
Good planning and organizational skills.
Good communication skills (oral and written).
Hardworking and highly motivating individual, with good attention to detail.
Proficient in use of Microsoft Office.
Ability to work both independently and as part of a team.
Ability to work in a dynamic environment, with changing priorities.
