Jacek Zagawa

- Maintenance of test flows within the Reliability labs
- Operation of the environmental, mechanical and operational stress test equipment
- Programming, debugging and other improvement activities
- Preparation of optical, electrical and mechanical test structures for evaluation
- Execution of critical optical/electrical/mechanical tests on to support development programmes
- Liaise with the Reliability Engineers to ensure appropriate planning and scheduling of key environmental, mechanical and operational stress tests
- Data capture and analysis to support the team of Reliability Engineers
- Liaise with the Reliability Engineers to provide feedback on failure modes and potential improvement activities
- Development of process instructions for key operations within the Reliability team
- Support the company’s Health & Safety policies by ensuring best practice within the reliability labs
- Preparation, scheduling and execution of key reliability tests
Timely provision of test results and regular updating on display performance and failure modes

Responsibility for the introduction of required procedures, specifications, quality assurance and inspection programmes required to ensure that the Company’s medical device manufacture adheres to the quality requirements of EU (and US regulatory) requirements and progression through clinical trials to commercialisation to enable the company to achieve its objectives. Support to the Quality Manager in maintaining a Quality Management System in accordance with EU (and US) regulatory requirements.

Responsibilities:

- Development of inspection programme and hand-over to manufacturing
- Development and control of Quality Specifications
- Management of the manufacturing calibration programme
- QA approval of deviations and concessions
- Execution of QA-related training
- Execution of manufacturing audits
- Ensure compliance of all product manufacturing documentation, including , Standard Operation Procedures (SOP’s), Manufacturing Proces Instructions (MPI), Quality Process Specifications (QPS’s), Batch Cards (BAT’s) and Gauge Calibration Specifications (CAL’s)

Equipment and Duties:

OGP Smart Scope CNC Critical Dimension Metrology System.
As the lead programmer for critical metrology I generated metrology scripts to measure moulds, jigs and final products in order to control prototype product performance. Using Measure-X software, I was required to check that the incoming assembly parts (moulds) correspond to their original design. To do this I developed inspection programs based on the engineering drawings provided.