Quality Systems Engineer

Quality Systems Engineer – Hybrid / Witney, Oxfordshire – £40,000-£45,000 – ISO13485 Experience Needed!

Interested in Hybrid working, a market-leading set of benefits and a new implementation of ISO13485?

My client is a leading electronic manufacturer seeking a Quality Professional to assist their expansion into the medical space.

As the successful Quality Systems Engineer you will be responsible for implementing and maintaining ISO13485 across the site. The role requires someone who is adaptable and able to understand and work with high technology products, speaking to customers with confidence regarding the company product portfolio and services.

This role encourages progression to management.

The Package
* Salary – £40,000-£45,000
* Hybrid working offered (2 days in office once settled)
* 25 days holiday + bank holidays, increasing with length of service
* One Friday off per month
* 3% company pension
* Health cash plan
* Life insurance
* Cycle to work scheme

The Role:
* Implement quality vision, strategy, policies, processes and procedures.
* Drive continuous improvements.
* Implement methodologies to ensure that products and services exceeds customer needs within project timescales
* Lead effective implementation of my client’s QMS throughout the company (ISO13485 & ISO14001)
* Lead 3rd party audits and accreditations.
* Utilise KPIs and other suitable tools to measure.
* Maintain Quality System and regulatory compliance, including continual review and implementation of changes.
* Lead internal audits program.
* Liaise with external regulatory and customer auditors, leading and managing audit teams as required to ensure compliance.
* Collate, summarise and communicate quality performance through metrics data.
* Liaise with cross functional teams and external stakeholders to implement an effective, documented process that defines quality requirements, best practices and training materials to support continuous improvement initiatives

Requirements:
* Must have experience in Quality System implementation (ISO9001, ISO13485, ISO14001)
* Must have experience maintaining and ideally implementing ISO13485.
* Must be an experience practitioner of Quality tools such as FMEA, SPCM, 8D, DMAIC, Six Sigma
* Lead Auditor ISO9001 and/or ISO13485 is desirable.

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