Principal Quality Engineer
We are seeking a Principal Quality Engineer to join our team at {company}.
About the Role
The Principal Quality Engineer will work as part of the Quality and Regulatory Affairs teams, responsible for tasks related to the development and maintenance of quality systems to support the organization.
Main Responsibilities
* Support the VP of Quality and Regulatory Affairs in developing and maintaining a quality system compliant with ISO and 21 CFR Part820.
* Participate in risk management process to ensure capture and mitigation of all risks in accordance with ISO requirements.
* Liaise with technical operations function to support manufacture of high-quality devices in compliance with procedures and regulations.
* Prepare quality system metrics to support management meetings and reviews.
* Address customer complaints in compliance with regulations, adhering to vigilance and reporting requirements.
* Manage CAPA system ensuring comprehensive root cause analysis and documentation.
* Maintain computerized system validation according to documented procedures and regulations.
* Maintain internal audit system, addressing non-conformances and recommendations in a timely manner.
* Support supplier management programme ensuring sub-contractors, suppliers, and external parties meet quality system requirements.
* Prepare reports, documents, and specifications to ensure project success.
* Support continuous improvement of quality system processes and business generally.
Requirements
* Bachelor's degree in Science or Engineering is a prerequisite for this role.
* A minimum of eight years' experience in quality engineering or regulatory role, ideally in the medical device industry.
* Excellent written, interpersonal communication, and presentation skills.
* Ability to effectively present information to peers.
* Self-starter who can see and deliver work required to advance company goals with minimal direction.
* Excellent communication skills, summarizing information from different sources.
* Solid grasp of team dynamics, participating in teams that deliver outstanding results.
* Holding oneself and others accountable to meet commitments.
* Prioritizing critical objectives amongst numerous project tasks and activities.