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Quality Systems Engineer

Quality Systems Engineer

Job Title: Quality Systems Engineer
Contract Type: Contract
Location: Dunfermline
Industry:
Salary: Competitive
Start Date: ASAP
Reference: 15813 JM
Contact Name: Julie McEwan
Contact Email: julie.mcewan@nextphaserecruitment.com
Job Published: April 06, 2018 16:33

Job Description

Do you have experience within medical device QMS.
Do you understand risk assessment processes and their effects on product development and change control?
Looking for a new challenge and a career within innovative manufacture?

The Role

My client, a medical device manufacturer based in Dunfermline require a Quality Systems Engineer to join their Quality Assurance team. You will be responsible for implementing and overseeing the QMS alongside all QA review and approval processes. From managing documentation, such as Standard Operating Procedures to Route Cards and Work Instructions to Certificates of Conformance, to provided support during third-party audits, you will be an integral part of team and as such will need to have commercial awareness of FDA/MHRA regulatory considerations for medical devices. 

The Company

A growing medical device company, operating on a global platform that specialises in the diagnosis, treatment and prevention of retinal diseases and disorders. With over 25 years’ experience within this sector to draw upon they are at the forefront of innovation.  Placing high importance on work/life balance the company believe that professional and personal goals are of equal importance and provide an environment where both can be realised. A competitive salary and extensive benefits package are offered complementing a friendly and supportive company environment and valued employee ethos. 

Benefits

A competitive salary is offered backed by an extensive benefits package including generous annual leave, company bonus, contributory pension, flexi-time, private health care and insurance schemes.  The company believe their employees are their most valuable asset. 

Experience

The successful candidate will have career experience gained within a regulated environment (ISO13485 preferably, but ISO9001 will also be considered) with a medium to high volume production output. You will also need to be an excellent communicator and analytical in nature in order to drive the CAPA process company wide and confident in your technical abilities to expertly guide the company through the audit process. Previous use of Compliant Pro as a QMS and experience of ISO14001 implementation would also be highly advantageous.

Please get in touch to find out more about this opportunity.