Description
I have an immediate opening for a Quality Engineer with my client, a global contract manufacturing solutions provider to the medical device and pharmaceutical industries, based in Dublin. This will be a maternity leave cover contract position with a very competitive salary on offer.The successful candidate will liaise with companywide 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.
Essential Duties and 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 TGED Quality system ie Drawings; Purchase Specification; Quality Agreements etc. and the training out of relevant personnel.
- Drafting and approving of quality documentation to meet TGED 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.
This is an excellent opportunity to join a leading medical device company based in Dublin. This role offers a huge range of experience for Engineers looking to improve and work within a fast paced, high volume manufacturing environment.
If you feel you are a good fit and are interested in hearing more, please apply directly to this advert call Derek Sheridan on for further information.