The Quality Engineer will support the Quality Manager to ensure that the Quality Management System and quality standards of the company are implemented and maintained. The Quality Engineer will also assist in project work.
Duties and Responsibilities:
- Interface on an ongoing basis with customers to ensure requirements / concerns/complaints are communicated and corrective and preventive 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 of relevant personnel.
- Drafting and approving of quality documentation to meet QMS and Customer requirements ie Quality Specification Sheets (QSS), CAPA’s, Defect Library etc.
- Trending and track of quality data to support quality improvements across the business
- Lead investigations into material / product issues to ensure a thorough root cause, containment / corrective and preventive action is implemented.
- Adherence to incoming control requirements and supporting the SCAR process when required.
- Participate in the review of validation protocols and reports to ensure quality compliance.
- 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.
- 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 13485 is essential.
- Ideally have an understanding of plastic process manufacturing.
- Must have an in-depth knowledge of validations and change control management in a Medical Device environment
- Must have a working knowledge of statistics, SPC, and ideally the use of Minitab.
- Must have excellent communication skills both oral and written.
- Auditing experience to the requirements of ISO 13485 is preferred.
- Ideally have a working knowledge of Lean / 6 Sigma tools.