Quality Management Specialist

Aurora Lifesciences has now partnered with a medical device company that are now in search of a QMS Specialist to join their growing QA function. Their state of the art product has multiple functionalities across medical device applications.

You will be responsible for all things Quality Systems (ISO13485) from development and implementation through to ensuring the product is compliant to MDR. This position necessitates a meticulous individual with leadership abilities and a drive to continually enhance quality processes.

Responsibilities

- Ownership on the QMS ISO13485, ISO9001

- Lead Internal and Support External Audit

- Ability to work with multi disciplined team

- Champion Quality Policies & Procedures and Documentation

- NC, CAPA, Change Control

- Continuous Improvement within QMS

- On site Quality Management SME

Skills

- QMS ISO13485

- Experience working with Medical Software (EN60601, IEC62304) - High Desirable

- Knowledge of Global Regulatory Requirement, FDA, MDR

Benefit

- 33 Day Holiday Inclusive of Bank Holiday

- Health Care

- Private Medical inclusive of Optical

- Private Dental

- Life Insurance

- Pension 10% Contribution

For more information about this fantastic oppunity please get in touch