Our client, a high-potential and well-funded startup company, seeks a Principal Quality Engineer to support the development and maintenance of their quality systems. This role reports directly to the VP of Quality and Regulatory Affairs.
The Principal Quality Engineer will be responsible for tasks related to the development and maintenance of quality systems that meet regulatory requirements, such as ISO 13485 and FDA's Quality System Regulation (21 CFR Part 820).
Key Responsibilities:
1. Collaborate with the VP of Quality and Regulatory Affairs to develop and maintain a compliant quality system.
2. Manage document control functions to ensure consistency and compliance across all documents.
3. Represent the quality function at functional team meetings and provide guidance to teams to achieve objectives.
4. Participate in risk management processes to identify and mitigate risks in accordance with ISO 13485 standards.
5. Liaise with technical operations to ensure high-quality product delivery in compliance with procedures and regulations.
6. Prepare quality system metrics for management meetings and reviews.
7. Address customer complaints in compliance with regulations and relevant vigilance and reporting requirements.
8. Manage CAPA systems to address observations and ensure root cause analysis is completed and documented comprehensively.
9. Maintain Computerised System Validation in accordance with documented procedures and regulations.
10. Promote continuous improvement of quality system processes and the business.
Requirements:
* Bachelor's degree in Science or Engineering is required.
* A minimum of eight years' experience in a quality engineering or regulatory role, preferably in the medical device industry.
* Excellent written, interpersonal communication, and presentation skills.
* Able to work independently with minimal direction and deliver results that advance company goals.
* Strong communication skills, including summarizing information from different sources and presenting it coherently.
* Ability to prioritize critical objectives among numerous project tasks and activities.