This is a fantasy opportunity for a Senior Quality Engineer to join a Global Medical Device company based in North Yorkshire. You will be responsible for supporting the compliance team to ensure all required certification is maintained.

Main Tasks/Responsibilities:

Complete internal audits in compliance with ISO 13485, 21 CFR, MDD/MDR and UKCA regulations.

Responsible for the logging, investigating, and documenting of non-conformities, ensuring appropriate action is taken to correct the issue and prevent recurrence, these must be completed within appropriate timescales including:

Corrective and Preventative Action Reports (CAPA)

Non-Conformity Reports (NC)

Regulatory reporting

Prepare trending analysis data whilst escalating any trends to a CAPA. Assist with preparation for the Quality Review Meeting.

Assist in the implementation of compliant processes and QMS documentation across multiple sites.

Responsible for the review and implementation of third-party agreements.

Undertake any other duties as may be requested.

Knowledge and Qualifications:

Essential:

Experience of working in a Quality environment, within the Medical Device Industry.

Experience of auditing to ISO 13485, preferably at Lead Auditor level.

Experience of generating and completing CAPA/Complaints and Root Cause Analysis.

Desirable:

Experience/knowledge of auditing the MDR, 21 CFR and UKCA regulations.

Experience/knowledge of reporting incidents to competent authorities.

Experience in writing processes compliant with standards.

Experience of ISO 14001.

Skills/Competencies:

Excellent interpersonal skills, including the ability to work as part of a team and to work with people from across the whole company.

Good organisation and leadership skills and attention to detail.

Good written and verbal communication skills.

A can-do attitude with the ability to take initiative and work to deadlines across multiple simultaneous tasks and projects

Problem Solver

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.

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