Description
I have an immediate job opening for a Quality Engineer with a leading medical device company based in Dublin. This is a fantastic opportunity to join a rapidly growing company on a permanent basis.You will be responsible for liaising with company wide departments to ensure internal system compliance and customer specifications are achieved. Ensure the timely and effective closure of internal/external quality issues. Coach and drive a culture of compliance and continuous improvement.
Requirements:
- Must have a third level qualification in Engineering/Quality/Science.
- Must have 2+ years work experience in a Medical Device manufacturing environment.
- A working knowledge of quality systems such as ISO CFR Part 820 is essential.
- Must have a working knowledge of statistics, SPC, and ideally the use of Minitab.
- Must have an in-depth knowledge of validations in a Medical Device environment.
- Must have excellent communication skills both oral and written.
- Auditing experience to the requirements of ISO CFR Part 820 is preferred.
Responsibilities:
- Interface on an ongoing basis with customers to ensure requirements / concerns/complaints are communicated and corrective actions are closed in a timely and effective manner.
- Management of customer documents into the Quality system ie Drawings; Purchase Specification; Quality Agreements etc. and the training out of relevant personnel.
- Drafting and approving of quality documentation to meet company and Customer requirements ie Quality Specification Sheets (QSS), CAPA's, Defect Library etc.
- Participate in the review of validation protocols and reports to ensure quality compliance.
- Review of quality document to drive compliance ie batch reports, metrology reports etc.
- Executing internal process and system audits.
- Manage quality projects in support of continuous improvement eg. Lean Projects.
- Co-ordinate activities associated with change management and customer interaction.
- Ensuring the timely and effective closure of day-to-day quality issues.
- Interface with other departments on a daily basis.
- Batch paperwork review and final decision to release product for shipment
- Analysing and reporting of key measures eg. Ppk's, Cpk's, Cost of Quality, Customer Complaints, and Internal/external quality results.
If you are interested in these excellent opportunities please apply directly to this advert or contact Derek Sheridan on for immediate consideration.