Quality Engineer| Westmeath| Permanent
Reporting to the Senior Quality Engineer, the Quality Engineer will support the development of a new manufacturing process at the site and enhance the process and related quality system over time. Customer onboarding and interaction is a significant element of the position.
Quality Engineer responsibilities:
- Lead quality improvement programmes using recognised problem-solving and project management techniques
- 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. Customer onboarding process is a key element of the position.
- Management of customer documents into the Quality system i.e., Drawings; Purchase Specification; Quality Agreements etc. and the training out of relevant personnel.
- Drafting and approving of quality documentation to meet Customer requirements i.e., 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 e.g., Lean Projects.
- Co-ordinate activities associated with change management and customer interaction.
- Ensuring the timely and effective closure of day-to-day quality issues.
- Batch paperwork review and final decision to release product for shipment
- Coach and drive a culture of compliance and continuous improvement.
- Compliance to all site Environmental, Health and Safety requirements, training and regulations.
Quality Engineer Requirements:
- Third level qualification in Engineering / Quality / Science.
- 2+ years’ work experience in a Medical Device manufacturing environment is essential.
- A working knowledge of quality systems such as ISO 13485 is essential.
- An in-depth knowledge of validations and change control management in a Medical Device environment.
- Auditing experience to the requirements of ISO 13485 / EU GMP / 21 CFR Part 820 is preferred.
**FULL SPEC ON REQUEST**
For a confidential discussion, please contact Tina Cornally.