Our client is seeking a dedicated and detail-oriented Quality Engineer to join the Operations team. The ideal candidate will play a pivotal role in ensuring the quality and compliance of our manufacturing processes, contributing to the delivery of medical devices that change lives.
Responsibilities:
- Develop, implement, and maintain quality assurance procedures and methods for control of materials and finished goods for the clients’ medical devices.
- Work as a key member of the operations team and with suppliers to ensure quality standards are met and maintained.
- Develop and execute product quality control plans, documents, and procedures.
- Provides input to risk analyses and Process Failure Mode Effect Analysis’ (pFMEAs) including with suppliers.
- Implement and enhance quality principles, gather, and analyse quality data to support product/process improvement activities.
- Oversee manufacturing related quality events in line with GMP and internal procedures, including process defects, CAPA, and complaint investigations. Disposition non-conforming material and work with manufacturer and suppliers to implement corrective and preventive actions.
- Provide quality guidance as an integral member of the operations team, influencing manufacturing activities.
- Provide quality input into process validation activities.
- Monitor quality records’ compliance and maintain documentation according to Quality System requirements.
- Assist with change control and calibration activities.
Requirements:
- BE/BS Degree. A post-graduate qualification in Quality Assurance is preferable although not mandatory.
- At least three to five years Quality Engineering experience or related role within the medical device industry.
- Experienced working in a medical device manufacturing environment complying with Good Manufacturing Practices.
- Ability to work on own initiative with limited supervision/guidance.
- Strong team member with the ability to identify and drive implementation of innovative quality improvements.
- Ability to collaborate and work with external suppliers and project teams, consistently meeting deadlines and ensuring that all actions are being addressed appropriately.
- Demonstrate and actively promote high levels of professional quality engineering.
- Good communication skills. Must have the ability to communicate effectively at all levels of the company and with suppliers.
- Process Validation experience desirable.
- Good administrative/organizational ability with high level of attention to detail.
- Ability to liaise with suppliers, customers, and regulatory contacts in an informed professional manner.
Thorough understanding of ISO 13485 and FDA QSR standards.
The above is not an extensive list of responsibilities, other duties not listed may be required as business needs arise.
