Principal Quality Engineer
We are seeking a Principal Quality Engineer to join our team at {company}, a high potential and well-funded startup company.
Role/Responsibilities:
* Support the development and maintenance of a quality system in compliance with ISO and 21CFR Part820.
* Manage the document control function, ensuring all documents are processed consistently and compliantly.
* Represent the quality function at functional team meetings, providing advice and completing documentation reviews in a timely manner.
* Participate in risk management, ensuring all risks are captured and mitigated according to ISO requirements.
* Liaise with technical operations to support device manufacture, ensuring high-quality products are delivered in compliance with procedures and regulations.
* Prepare quality system metrics for management meetings and review.
* Ensure customer complaints are addressed in compliance with relevant regulations.
* Implement the CAPA system, addressing observations and conducting comprehensive root cause analysis.
* Maintain Computerised System Validation and internal audit systems.
* Support supplier management, ensuring sub-contractors and suppliers meet quality system requirements.
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.
* A self-starter who can deliver work required to advance company goals with minimal direction.
* Excellent communications skills, summarizing information effectively and participating in teams that deliver outstanding results.
* Prioritization and focus on critical objectives amidst numerous project tasks and activities.