Job Description
GXPeople have partnered with a Medical Device Manufacturer in their search for a Quality Engineer or Senior Quality Engineer to join the team at their Manchester headquarters.
Read on to find out what you will need to succeed in this position, including skills, qualifications, and experience.
You will be part of innovative company who are at the forefront of their therapeutic area and the first ones to have developed these types of devices
The position is a full-time office based role located at their headquarters near Manchester, reporting to the Quality Manager and involving both Quality Assurance activities e.g., supplier management and development of the QMS system; and Quality Control activities e.g., product inspection and release.
Responsibilities:
- Supplier Management (SCARS, KPl’s, Supplier Assessments, Supplier Agreements, supplier requalification, supplier monitoring)
- External audits of suppliers
- Non-conformances (NCMR and CAPA)
- Customer Complaints
- Product inspection
- Review, inspection and authorisation of labels
- Review & approval of Device History Records (DHR) and other production documentation
- Execute Product Release
- Revision of existing QMS documentation (SOP’s, WI’s policies)
- Contribution to the development of new QMS procedure
Essential Experience:
A familiarity with operating to ISO13485 and compliant processes & procedures
QA and preferably QC experience in a medical device company
Degree qualified or quality qualification
Minimum 2 years’ experience in a relevant work setting
If you would like to find out more please apply or getting in touch with me.