Quality & Regulatory Manager

Recruiter
Clinitemp Ltd
Location
Dover, UK
Salary
Competitive
Posted
16 Sep 2019
Closes
19 Sep 2019
Ref
1211736353
Sector
Engineering
Contract Type
Permanent
Hours
Full Time
Job Title: Quality & Regulatory Manager

Job Type: Permanent

Location: Kent

Salary: £40,000

JOB SUMMARY:

* To ensure that the company is fully compliant in its manufacturing and supply of medical devices to enable the safe and reliable treatment of patients.

* To operationally oversee that the Quality Management System is being implemented to standard in all areas.

* To ensure the whole supply chain and distribution network is established, maintained and managed in order to attain the required regulatory compliance standards and to achieve the optimum quality and value for the company.

* To ensure that we have a progressive and structured programme of future medical device development, adding value by increased efficiency and the accumulation of intellectual property.

Responsibilities:

* Oversee the continuous attainment of CE and EN ISO 13485:2016 accreditation and all audit and operational requirements needed to do so.

* Ensure that full quality control systems are in place and operated consistently on all equipment before it is released for service

* Ensure that treatments kits are used in order by date of manufacture and that any out of date Equipment is retired and properly disposed of

* Ensure compliance with and recording of any periodic testing requirements for Equipment is conducted to standard.

* In case of any failures of or defects in Equipment, determine the root cause and work with manufacturers to remedy any issues with their performance

* Propose and receive proposals for improvements to Equipment and manage any resulting design and development programmes approved by the Board

* Manage the resolution of corrective actions and non-conformities raised through the audit process

Qualifications:

* At least 5 years' experience or training in: manufacturing, quality assurance and overseeing compliance with regulations and standards in connection with medical devices

* EN ISO 13485:2016

* QMS and Technical File auditing

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