Job Summary

The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System at PBC BioMed 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. Experience of NPIs 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.
• Support the operation of QMS functions, such as:
• 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 and Education Requirements

• 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.

Note: This description reflects essential functions and does not prescribe nor restrict tasks that may be assigned.