Job Overview
The Principal Quality Engineer will lead the development and maintenance of quality systems to support our business. This role is responsible for ensuring compliance with ISO 13485:2016 and 21CFR Part820.
Key Responsibilities
1. Develop and maintain quality systems in accordance with regulatory requirements, driving consistency and excellence across our operations.
2. Manage document control functions to ensure seamless and compliant processing of documents, fostering a culture of transparency and accountability.
3. Represent the quality function at team meetings, providing expert advice to support strategic objectives and drive business outcomes.
4. Participate in risk management processes to capture and mitigate risks, ensuring the delivery of high-quality products that meet customer needs.
5. Liaise with technical operations to support device manufacture, guaranteeing the highest standards of quality and reliability.
6. Prepare quality system metrics for management meetings and review, enabling data-driven decision-making and continuous improvement.
7. Address customer complaints in compliance with regulations and reporting requirements, maintaining a strong reputation for quality and service.
8. Manage CAPA systems, computerised system validation, internal audits, supplier management, and prepare technical documents, ensuring the efficient execution of quality-related tasks.
9. Support continuous improvement of quality system processes and the business, driving innovation and growth through quality excellence.
Required Skills and Qualifications
* Bachelor's degree in Science or Engineering, demonstrating a solid foundation in technical knowledge and principles.
* A minimum of eight years' experience in quality engineering or regulatory roles, ideally in the medical device industry, showcasing a proven track record of success and expertise.
* Excellent written, interpersonal communication, and presentation skills, enabling effective collaboration and stakeholder engagement.
* A self-starter with strong ability to see and deliver work required to advance company goals, demonstrating initiative and a results-oriented mindset.
* Strong communications skills, team dynamics, and accountability, fostering a positive and productive work environment.