Supplier Quality Engineer - Leeds, Cork, Zuchwil & Home Based
George Truman at CK Technical is recruiting for a Supplier Quality Engineer to join a company in the Life Sciences industry on a contract basis. This role will be based in Leeds, Cork, Zuchwil or Home Based.
Our client has one of the world's most comprehensive portfolio of orthopaedic and neuro products and services for joint reconstruction, trauma, spine, sports medicine, neuro, cranio-maxillofacial, power tools and biomaterials.
The role would be based at one of our client's sites in Leeds, Cork - Ireland, Zuchwil - Switzerland or Home Based. Initially you will be required to spend a training week at one of these sites.
The main purpose of the role will be to:
- Work with Suppliers to meet EU MDR requirements and resolve issues with obtaining Supplier Product information.
Further responsibilities will include:
- Partner with Supply Chain to support EU MDR supplier communications and rollout of EU MDR Supply Chain Workstream activities.
- Support definition and clarification of EU MDR supplier related process requirements.
- Support Review and Approval EU MDR Change Projects as applicable.
- Support Supplier Quality Functional Impact Assessments as applicable.- Support Review and Approval of supplier Process Validation Protocols and Reports as applicable.
- Support the update of supplier related Inspection Criteria as applicable.
To succeed in this role, you will come from a background in Supplier Quality Engineering with at least 3 years experience in Quality Engineering.
You will also have:
- A minimum of a Bachelor's degree or equivalent in Engineering or associated technical field is required.
- Familiarity with ISO 13485 and FDA QSR is required.
- Excellent organizational skills and attention to detail is required.
- Must be able to work independently and prioritize with limited supervision.
- Strong written and oral communication and interpersonal (listening) skills.
- Excellent computer, communication, and written skills are required.
- Understanding supplier management and validation procedures and execution.
- Strong background in Medical Device Regulatory Compliance/Regulatory Affairs.
- Experience working with suppliers across multiple sites and franchises.
- Ability to act as an SME in supplier business processes.
- Experience with medical device technical files.
For more information or to apply for this position, please contact George Truman on 01246 457736 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45052 in all correspondence.