Quality & Regulatory Engineer

Enterprise Recruitment Limited
09 Mar 2018
17 Mar 2018
Contract Type
Full Time
Quality & Regulatory Engineer

We are currently seeking an experienced Quality & Regulatory Engineer to join a leading medical device company. You will work as part of a multi-disciplinary quality team who have a broad remit to ensure the ongoing compliance of products and systems to the appropriate standards and regulations as the company continues to expand into new markets. Day to day responsibilities will include;

- Maintain and develop the quality manual and associated procedures.
- Work with the relative authorities and internal departments to ensure that adverse incidents are reported correctly.
- Work closely with the design department to ensure ongoing regulatory compliance of current and future products.
- Produce a month Return in Warranty report.
- Assist in the monitoring of NCRs, customer complaints and CAPA reports.
- Identify and implement areas where corrective or preventative action is required to aid in continuous improvement.
- Be a part of the internal audit team.

Quality & Regulatory Engineer Requirements:

- Relevant experience within a manufacturing environment.
- Experience of the medical device standards ISO 13485 and the medical device directive or experience working within other highly regulated industries.
- Experience of working in international markets is desirable.
- An understanding of FDA regulatory and QMS requirements is highly desirable.


Position: Quality & Regulatory Engineer

Location: Aylesbury

Salary: £26-30k/pa, plus bonus

This job was originally posted as www.jobsite.co.uk/job/960303285

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