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Principal Quality Engineer

Job Description

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.