Unit 4D, Western Business Park, Shannon, Co.
Clare
Job Summary
The Quality Assurance associate role will involve supporting the implementation of the Quality Management System across the PBC group.
Maintaining compliance to ********(MDR), ISO *****, ISO **** and FDA Part 4 standards and requirements.
The scope of the QMS includes the Design and Development, manufacture and secondary packaging and distribution of medical devices.
Job Category
Quality Assurance
Job Description
Role and Responsibilities
Ensure the effective implementation and maintenance of the Quality Management System.
Perform QA Verification of activities performed in intake, manufacture & distribution.
Support the operation of QMS functions, such as Change Controls, CAPAs and Non-Conformance documentation, documentation control, Employee Training, design & development controls.
Support continuous improvement initiatives based on quality objectives.
Participate in Notified Body Audits and Audit preparation as requested.
Generate reports as required and assist in any other data compilation as requested.
Assist in other projects as required.
Qualifications and Education Requirements
Qualifications: Third level qualification in natural sciences (Certificate, Diploma, Degree level)
Good planning and organizational skills.
2+ years' experience in a highly regulated industry (Pharma, food, medical devices).
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.
Note: This description reflects essential functions and does not prescribe nor restrict tasks that may be assigned.
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