Job title:

Quality Engineer Location

: Sudbury, Suffolk Contract Length:

12 months Randstad Sourceright is proud to support a global leader in Medical Technology company to recruit an Quality Engineer to be based from their Sudbury site in Suffolk. Job Role The Quality Operations Engineer will be responsible for maintaining, monitoring, and improving key elements of the Quality Management System (QMS) for the Sudbury Site, developing a culture of Quality by education, mentoring and example.

The role is responsible for: Provide Quality support to the Manufacturing Operations Team

Support CAPA & Issue Resolution to ensure timely and accurate completion.

Administer & support the deviation process to ensure timely and accurate completion.

Administer & support the quality notification process to ensure timely and accurate completion.

Prepare for supplier, customer, regulatory & notified body audits as required.

Conduct internal & supplier quality audits as required.

Support the change control process.

Prepare, review, and approve or reject quality related documentation.

Provide support for training in key aspects of the Quality Management System.

Generate quality related metrics, reports and KPI's and lead improvement projects and quality initiatives.

Participate in SQDIP meetings, provide accurate and timely reports, and take responsibility for the achievement of target KPI's for the role.

Requirements for the role: Quality experience in a medical manufacturing environment

In depth knowledge of Quality Management Systems, ISO 13485, 21 CFR 820

IT literate with strong knowledge of Microsoft Office packages.

GDP & GMP (Good Documentation Practices & Good Manufacturing Practices)

We are committed to providing equal employment opportunities and encourage all qualified candidates to apply. While the hiring process may not be expedited, we urge all interested candidates to submit their applications promptly to ensure their consideration. If this isnt the role youre looking for right now, please visit our contractor portal below where you will see all of our live roles and communities to join:

https://contractortalent.gr8people.eu/

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