Our client a medical device company in Clare is looking to hire a Supplier & Logistics Quality Engineer for their site on a maternity cover contract. You will be responsible for Supplier Assurance activities across our site.
- Auditing of proposed and current suppliers as well as establishment of audit schedule
- Supplier liaison and evaluation – including review (scoring) of vendor supplied information via self-assessment.
- Ensuring that all Supplier Assurance activities are completed with accuracy and compliance.
- Communicate with suppliers such as following up on supplier root cause & corrective actions as required (SCAR).
- Complete Supplier Change Notifications (SCNs), as necessary.
- Maintain Supplier Files documentation ensuring compliant Supplier Files including ISO certificates.
- Co-ordinate the non-conformance process for handling non-conforming materials (Internal/Supplier NCs) ensuring compliance to procedures, in a timely manner, and ensuring compliance with Quality and Regulatory Standards.
- Involvement in Internal Auditing Process as well as representing Supplier Quality in both internal and external audits.
- Quality Assurance responsibilities on Design Projects, if applicable.
- Perform CAPA activities, as required.
- Initiate, review and approve document change controls ensuring Good documentation practices are maintained and comply with company procedures.
- Analyse and report meaningful quality metrics to ensure on-going improvement programmes are put in place and continually strive for customer satisfaction
- Enforce strict house-keeping standards in own area of responsibility and across Supplier Assurance and Logistics area.
- Ensuring area procedures as well as operational area procedures are updated as necessary and correct.
- Encouragement of team-work within the area as well as involvement where appropriate in plants cross-functional problem solving initiatives.
- Ensure quality issues are communicated to management such that they are aware of any significant variance from targets or potential opportunities or problems.
- Generate, update, implement and complete associated training for relevant departmental procedures, as required.
- Duties as prescribed by the Supplier Quality Manager.
- B.Sc or M.Sc. in chemistry, biochemistry, microbiology, engineering or other relevant technical field
- At least 2 years’ experience in QA in an FDA regulated industry
- A good knowledge of ISO9001/ISO13485, FDA and GMP.
- Strong Interpersonal and communication skills.
For further information on this Supplier & Logistics Quality Engineer role please contact Clara Burke on 086 8168273/ email@example.com
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