Job Purpose:
The Quality Technician plays a crucial role in ensuring that products adhere to the necessary quality standards and regulatory requirements.
Key Responsibilities:
* Management of non-conformances, Technical writing abilities including, disposition, investigation/root cause analysis and implementing corrective actions.
* In-process product testing as needed.
* Follow up on Corrective Actions for in-process production NCs and customer complaint issues.
* Conduct area practice v's procedure audits and follow up on findings to ensure satisfactory closure.
* Experience with Good Manufacturing Practices (GMP) in a medical device-related industry is required.
* Support improvement of QMS documentation (i.e. Raise Change Requests, Write Procedures etc).
* Support validation activities including first article inspections as required.
* Support NPI/manufacturing operations area projects and initiatives e,g, Kaizen, yield improvement, cost reduction etc
* Additional responsibilities as assigned by supervisor/manager
Education and Experience:
* Bachelor's degree in science, Quality, Engineering, Manufacturing, or related field is desirable but not essential
* Decision-making ability while also working on one's initiative.
* Thorough knowledge of medical device quality systems.
* Must be innovative and be driven to implement changes to systems and procedures.
* Ability to Problem-solve including collecting data, establishing facts, and implementing actions.
* Must be able to communicate at all levels of the organisation and with customers, suppliers, and regulatory agencies.
* Excellent attention to detail.
* Excellent written and oral communication skills.
* Working knowledge of Microsoft Excel, Word, and PowerPoint General knowledge of commonly used measuring equipment and instrument selection.
* Working knowledge of calibration process.
* Ensuring compliance with applicable regulatory standards and internal GMP processes.