Quality engineer- Medical Device- Engineer- CAPA- Harlow- Essex
SRG are currently looking for a Quality Engineer to join a Medical Device client based in Harlow. This is an exciting time to join them as they are growing and have thrived during the pandemic.
As a quality engineer you will ensure the company readiness in compliance with standards and certifications along with the following:
* Assist in performing Post Market Surveillance.
* Member of internal auditor team
* interact with all areas of the business in order to process/co-ordinate:
- Customer complaint investigations,
- identify incidents of non-conformance
- support the company continual improvement and CAPA programme.
- approve and implement validation documentation
- Product CE marking and US submissions
You will also be responsible for:
1) Support the Quality & Regulatory manager in the general maintenance of BQMS, regularly update the quality system performance and reporting data
2) Create, review and update relevant SOPs and Work Instructions needed to support/improve BQMS, Including ownership of the document and data control process
3) Facilitator of Corrective Actions and provide performance report on periodic basis.
4) Provide support with CAPA, complaint and product investigation as needed
5) Provide training including generating training materials to attain necessary competence of personnel and/or increase their awareness of BQMS requirements
6) Maintain membership & subscriptions (e.g. BSI)
If you feel like you could be a good match please apply for this advert or send your CV to (url removed) or if you would like to find out more please feel free to call me on (phone number removed)