Principal Quality Engineer
We are seeking a Principal Quality Engineer to join our team. The successful candidate will report to the VP of Quality and Regulatory Affairs.
Key Responsibilities:
* Support the development and maintenance of a quality system in compliance with ISO and 21CFR Part820.
* Manage document control, ensuring consistent and compliant processing of all documents.
* Represent the quality function at functional team meetings, providing advice and completing documentation reviews.
* Participate in risk management to ensure captured risks are mitigated according to ISO requirements.
* Liaise with technical operations to support device manufacturing, ensuring high-quality product delivery.
* Prepare quality system metrics for management meetings and review.
* Address customer complaints in compliance with regulations.
* Manage CAPA systems, root cause analysis, and Computerised System Validation.
* Maintain internal audit systems, addressing non-conformances and recommendations.
* Support supplier management, ensuring adherence to quality system requirements.
* Prepare reports, procedures, specifications, and other technical documents as needed.
Requirements:
* Bachelor's degree in Science or Engineering.
* A minimum of eight years' experience in quality engineering or regulatory roles, preferably in the medical device industry.
* Excellent written, interpersonal communication, and presentation skills.
* Ability to present information effectively to peers.
* A self-starter who can advance company goals with minimal direction.
* Excellent communication skills, able to understand and summarize complex information.
* Solid grasp of team dynamics and ability to participate in high-performing teams.
Skills:
* Quality Systems Design
* Quality Engineering