Principal Quality Engineer


Our client a high potential and well-funded startup company are seeking a Principal Quality Engineer to join their team. Reporting to the VP of Quality and Regulatory Affairs. The Principal Quality Engineer will work as part of the Quality and Regulatory Affairs teams and be responsible for tasks that are related to the development and maintenance of the quality systems to support the organisation.


Role/Responsibilities:

• Support the VP of Quality and Regulatory Affairs in the development and maintenance of a quality system in compliance with ISO 13485:2016 and the quality system regulation 21CFR Part820.
• Manage the document control function for the group ensuring that all documents are processed in a consistent and compliant manner.
• Represent the quality function at functional team meetings and support the teams in meeting their objectives by providing advice and completing documentation reviews in a timely manner.
• Participate in the risk management process to ensure that all risks are captured in the risk management report and ensure that all risks are mitigated in accordance with the requirements of ISO 14971:2019.
• Liaise with technical operations function to support the manufacture of the organisations devices ensuring that high quality product is delivered in compliance with procedures and the regulations.
• Prepare quality system metrics on a pre-determined basis to support management meetings and for management review.
• Ensure that all customer complaints are addressed in compliance with the appropriate regulations, ensuring that all relevant vigilance and reporting requirements are adhered to.
• Manage and implement the CAPA system ensuring that all observations are addressed in accordance with the procedures ensuring that comprehensive root cause analysis is completed and documented appropriately comprehensively.
• Manages Computerised System Validation in accordance with documented procedures and regulations.
• Maintain the internal audit system ensuring that audits are completed on schedule and that all non-conformances, observations and recommendations are addressed in a timely manner.
• Support the supplier management programme ensuring that all sub-contractors, suppliers, and external parties meet and adhere to the requirements of the quality system.
• Prepare reports, documents, procedures, specifications, and other such technical documents as required to ensure the success of the project.
• Support the continuous improvement of quality system processes and the business generally.
• Complete additional 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 eight year’s experience in a quality engineering or regulatory role ideally in the medical device industry.
• Requires excellent written, interpersonal communication and presentation skills and an ability to effectively present information to peers.
• A self-starter who is able to see and deliver the work required to advance the company goals with a minimal amount of direction.
• Excellent communications skills: Can understand with ease virtually everything heard or read. Can summarize information from different spoken and written sources, reconstructing arguments and accounts in a coherent presentation.
• Has a solid grasp of team dynamics and is able to participate in teams that deliver outstanding results.
• 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.
• Able to prioritize and focus on the few critical objectives amongst numerous project tasks and activities.