Urgent Quality Assurance Associate

3 weeks ago

Shannon, Ireland PBC BioMed Full time

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 2017/745(MDR), ISO 13485, ISO 9001 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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