Supplier Quality Engineer
other jobs X Life Sciences Job
Added before 46 Days
- England,South East,Oxfordshire
- full-time
- £40,000 - £45,000 per annum
Job Description:
X4 are currently collaborating with a growing Medical Device company in the search for a highly skilled Supplier Quality Engineer to join their Oxford based team!
The role is 3 days on site in Oxford and depending on experince level we’re lookign at £40,000-£45,000 per annum.
Here’s an overview of what you will be doing:
* Auditing of key suppliers to ISO 9001:2016 and cGMP in accordance with the supplier audit schedule. This role will involve significant travel at times.
* Ensure all suppliers for are approved and routinely evaluated in accordance with ISO 13485:2016 and 21 CFR Part 820 (other territories may apply).
* Administer the Supplier Corrective Action Reports (SCAR) process, ensure all are raised and investigated within a timely manner.
* Support suppliers throughout the SCAR process, facilitating root cause analysis when required.
* Assist with the creation of KPIs to effectively manage and monitor supplier quality.
* Assist with new supplier approval process, including new supplier evaluation/re-evaluation.
* Support investigations of suppliers involved with any feedback, Post-Market Surveillance or customer complaints.
* Support the RMA process by liaising with suppliers and assisting with material transfer.
* Ensure all Design changes and implemented improvements and related SOP and other related documents are communicated to the supplier when required.
* Act as subject matter expert for area of expertise by maintaining knowledge of the relevant procedures and specifications related to current job specification, to include participating in and supporting external audits e.g. BSI, FDA etc.
Skills and Experience:
* Experince of working in Quality within the Medical Device industry.
* Supplier Audit Experince - ISO 13485, 21 CFR Part 820 Lead Auditor qualified.
* Working knowledge of GDP/GMP requirements.
* Ability to travel and be out of the country for considerable periods of time.
Please share your CV at e.smailes@x4 lifesciences.com if you are interested in hearing more about the position. As always if anyone in your network may be a good fit, please share their details as we offer a referral bonus upon the successful placement.
The role is 3 days on site in Oxford and depending on experince level we’re lookign at £40,000-£45,000 per annum.
Here’s an overview of what you will be doing:
* Auditing of key suppliers to ISO 9001:2016 and cGMP in accordance with the supplier audit schedule. This role will involve significant travel at times.
* Ensure all suppliers for are approved and routinely evaluated in accordance with ISO 13485:2016 and 21 CFR Part 820 (other territories may apply).
* Administer the Supplier Corrective Action Reports (SCAR) process, ensure all are raised and investigated within a timely manner.
* Support suppliers throughout the SCAR process, facilitating root cause analysis when required.
* Assist with the creation of KPIs to effectively manage and monitor supplier quality.
* Assist with new supplier approval process, including new supplier evaluation/re-evaluation.
* Support investigations of suppliers involved with any feedback, Post-Market Surveillance or customer complaints.
* Support the RMA process by liaising with suppliers and assisting with material transfer.
* Ensure all Design changes and implemented improvements and related SOP and other related documents are communicated to the supplier when required.
* Act as subject matter expert for area of expertise by maintaining knowledge of the relevant procedures and specifications related to current job specification, to include participating in and supporting external audits e.g. BSI, FDA etc.
Skills and Experience:
* Experince of working in Quality within the Medical Device industry.
* Supplier Audit Experince - ISO 13485, 21 CFR Part 820 Lead Auditor qualified.
* Working knowledge of GDP/GMP requirements.
* Ability to travel and be out of the country for considerable periods of time.
Please share your CV at e.smailes@x4 lifesciences.com if you are interested in hearing more about the position. As always if anyone in your network may be a good fit, please share their details as we offer a referral bonus upon the successful placement.
Job number 1549391