- Reference: LK44580
- Job Type: Permanent
- Location: Clare, Limerick, Tipperary
- Category: Engineering, Technical & Manufacturing
Collins McNicholas currently have an exciting opportunity for a permanent Quality Engineer – Medical Device with one of their clients in the Mid-West Region.
The following are the key requirements for the role
- Investigating root cause of quality problems and following through with appropriate and effective corrective actions to avoid re-occurrence for customer and internal issues.
- Propel quality improvement programs to achieve agreed performance targets in areas such as complaint (QN) levels, CAPA closure, scrap and in-process defect reduction, audit compliance
- Develop process quality control systems which will ensure success in the prevention of defects, and the detection of non-conformances as close to the occurrence point as possible. Include inspection points, methods and response plans to each possible outcome.
- Constant review of production processes and process quality control systems, using correct reporting (Customer complaints and failures, in-process failures, efficiency problems, etc.) to identify and execute improvement opportunities in the process quality control system.
- Examination of defects, analysis reports etc. to identify specific quality problem causes. Reporting the results of such investigations and relentlessly implementing the root cause resolution of such problems. Protect the customer and later processes through the appropriate use of containment actions.
- Support application of Lean Six Sigma tools such to ensure all failure modes are defined and addressed, or to monitor process performance
- Develop and implement process and system audits that will support the activities of process improvement and control.
- Support the company’s continued certification to ISO13485 and implement effective corrective action where non-conformance issues arise
- Ensure documentation required to support systems and processes are available and effective
- Support production through driving improvement and corrective action in the quality of components sourced from internal and external suppliers/ subcontractors.
- Finalize the required evaluations and part/equipment qualifications for new medical supplier prior to AVL approval
- Measures supplier capabilities through direct visits, technical discussions and involvement in quality system audits.
- Performs other related duties as assigned by management.
- Minimum 3 years related experience in a medical manufacturing environment essential
- Degree in Science / Engineering or related areas essential
- Qualification in Quality/Validation/Statistics would be a clear advantage
- Clear understanding medical device quality systems and requirements, including measurement techniques, would be a distinct advantage
- Strong working knowledge of FDA and ISO Quality systems for Medical device companies desirable
- Proven knowledge and experience of all aspects of Validation including Process Validation and Software Validation
- Strong root cause analytical and problem solving skills
- Working knowledge of SAP advantageous
- Working knowledge of quality tools such as SPC/Process Control, FEMEA, Problem Solving/Root Cause Analysis and other Six Sigma tools
- Six Sigma Greenbelt or Blackbelt desirable
For a confidential discussion on the above role please contact Michael O’Leary on 061-512270