Job Details
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| QA/Regulatory Engineer | | |
| Location: | | Europe (Non UK) | | |
Description
Job Description:
The successful candidate will have experience particularly in QA/regulatory environment. He/She will have experience of participating in medical device projects from concept to commercialisation and will have preferably lead the regulatory side of the project. The successful candidate will be responsible for overseeing and driving regulatory of Design services projects including design control, DHF & risk management
Job Responsibilities:
· Following design control procedures for Design services projects in compliance with ISO13485 and FDA QSR820.
· Lead project risk management including DFMEA
· Lead the project group and communicate with customers on various aspects of project regulatory and requirements.
· Execution of validation systems to ensure product transfer to production with the appropriate requirements
· Liaise with DS manufacturing during transfer of products to manufacturing.
· Drive projects process improvements with the DS group as required.
· Management New process validations and coordination of validation activates to meet project completion deadlines.
· Establishing inspection standards, plans, frequencies and test methods.
· Performing an active role in further development of the quality management system. This will involve: Performing internal and external audits to ISO and FDA requirements. Upgrading system elements as appropriate.
Key Requirements:
· Degree in engineering, science or other related discipline
· 3-5 years experience in medical device sector.
· 2-3 years working as part of team working in regulatory side of products, ideally the candidate will have led this part of the projects.
· Experience of ISO13485, FDA QSR 820, CE Mark process, 510K and PMA process.
· The successful candidate will have excellent communication skills
· Proven capability to work in a team, with sufficient innovation to lead projects deliverables as required by the group.
The recruiter is interested in your answers to the following question(s). Please place your answers in the email you send when applying for the job.
Question 1:
'Do you have a Degree in engineering, science or other related discipline with 3-5 years experience in medical device sector.'
Question 2:
Do you have 2-3 years working as part of team working in regulatory side of products, ideally having led this part of the projects
Question 3:
Do you have experience of ISO13485, FDA QSR 820, CE Mark process, 510K and PMA process | | |
Reference
IJ-MK/38240/IJP | | |
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