Senior QA Associate – Medical Devices – Global Medical Devices Company – Yorkshire with hybrid working - £competitive salary, bonus, pension, healthcare

This is an excellent opportunity to grow your QA career in a hugely successful, global medical devices company at their Yorkshire based head office.

The Company

A market leading, global medical devices company focusing on multiple therapy areas. Their highlights include;

• Global medical devices company
• Distribute a range of devices from Class I-III across multiple therapy areas
• Award winning company
• Excellent training and development opportunities
• Idyllic location with plenty of onsite parking

The Role

This is an exciting opportunity for someone develop their career in Quality Assurance in a market leading, global medical devices company. You’ll be responsible for supporting the compliance team to ensure all required certification is maintained.

• Complete internal audits in compliance with relevant standards (ISO 13485, 21 CFR, MDD/MDR and UKCA regulations)
• Assist in the logging, investigating, and documenting of all non-conformities
• Corrective and Preventative Action Reports (CAPA), Non-Conformity Reports (NC)
• Assist in the logging, investigating, and documenting of all product complaints
• Recall handling
• Prepare trending analysis data whilst escalating any trends to a CAPA.
• Create and revise Product Specification Documentation.
• Oversee and track external supplier audits and completion of actions.

You

To apply for this role as Senior QA Associate our client is hoping for someone with the following skills and experience;

• Ample experience in Quality Assurance specifically within medical devices
• Good knowledge of MDR is desired
• Knowledge of ISO 13485, ISO 9001 and knowledge of ISO 14001 is desirable
• Experience of Internal Audit, ideally as a lead auditor (desired)
• Experience of CAPA/Complaints and Root Cause Analysis.
• Experience in writing processes compliant with standards.
• Due to their location, you will need to have a driving licence and access to a vehicle on office days

What should you do next?

This Senior QA Associate role is one not to be missed; it encompasses the opportunity to work for a market leading, global medical devices company. To discuss this QA role further or to find out about other QA jobs I’m currently working on, please get in touch or hit apply to submit your current CV.

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