Quality Engineer – Operations


Our client a high potential and fast growing medical device start up currently seeks a Quality Engineer to join their team. The Quality Engineer will work as part of the Quality and Regulatory Affairs teams and be responsible for tasks supporting the Operations function.


Role/Responsibilities:

• Liaise with technical operations function to support the inspection and manufacturing activities at the OEM facility to ensure compliant product is consistently delivered.
• Develop and implement inspection procedures for incoming components, in process assemblies and final product and manage and co-ordinate all inspection activities.
• Manage and implement procedures for non-conforming product.
• Develop and maintain PFMEA and provide direction in the development of validation protocols and reports.
• Review DHR records and prepare product release documentation.
• Prepare quality system metrics on a pre-determined basis to support management meetings and for management review.
• Implement the CAPA system at ensuring that comprehensive root cause analysis is completed and that corrective and preventive actions are effectively implemented.
• Support the supplier management programme ensuring that all sub-contractors, suppliers, and external parties meet and adhere to the requirements of the quality system.
• Support the continuous improvement of quality system processes and the business generally.
• Complete tasks as designated by your supervisor to support the needs of the business.

• Bachelor’s degree in Science or Engineering is a pre-requisite for this role.
• A minimum of two years experience in a quality engineering or regulatory role ideally in a regulated environment. Medical device industry experience is an advantage.
• A self-starter who can see and deliver the work required to advance the company goals with a minimal amount of direction.
• Excellent written, interpersonal communication and presentation skills.
• Holds him/herself and others accountable to meet commitments by following through, acting with a clear sense of ownership, and taking personal responsibility for decisions, actions and failures.