Melio Life Science have partnered with a leading mid-size medical device company who are seeking an experienced and highly skilled Principal Quality Engineer to join their dynamic team.
As a key member of their Quality Assurance department, you will play a crucial role in ensuring the highest standards of quality and compliance in the development and manufacturing of their medical devices.
Lead the design, implementation, and maintenance of the QMS to ensure compliance with applicable regulations and standards (ISO 13485, FDA QSR, etc.).
Collaborate with regulatory affairs to support product registrations, submissions, and audits.
Conduct risk assessments and provide recommendations for risk mitigation strategies.
Lead quality activities during product development, including design control, verification, and validation.
Oversee the Corrective and Preventive Action (CAPA) process, including root cause analysis and effective resolution.
Manage records in accordance with regulatory requirements.
Bachelor's degree in Engineering or a related field; advanced degree preferred.
Extensive experience (8+ years) in quality engineering within the medical device industry.
Strong knowledge of regulatory requirements, including ISO 13485 and FDA QSR.
Proven experience in leading and implementing QMS processes and improvements.
In-depth understanding of risk management methodologies.
Excellent problem-solving skills with a focus on root cause analysis.
Strong leadership and communication skills, with the ability to collaborate across functions.
At least 1 year of EU MDR/ SaMD experience.
Competitive salary and performance-based incentives.
Comprehensive health and wellness benefits.
Opportunities for professional development and career advancement.
A collaborative and innovative work focused on improving healthcare outcome.