Senior Quality Engineer - Class III Medical Device
Location: Dublin (onsite)
Job Description: We're seeking a Senior Quality Engineer to support the development of a cutting-edge structural heart device. You will oversee design, verification, validation, clinical trials, and regulatory compliance to ensure the product meets the highest standards whilst reporting to the QA Manager.
Key Responsibilities:
- Collaborate with a cross-functional team to develop a transcatheter heart repair device.
- Ensure product quality through risk management, biocompatibility testing, and clinical evaluation.
- Develop and manage test methods for product validation and verification.
- Maintain compliance with ISO 13485, ensuring robust quality control throughout the supply chain.
- Conduct audits and supplier evaluations.
- Provide training on quality system requirements.
- Prepare and maintain regulatory-compliant documentation.
Essential Skills and Experience:
- Strong understanding of quality principles in medical device design and manufacturing.
- Excellent problem-solving and project management skills.
- Effective interpersonal and communication skills, including the ability to mentor junior team members.
- Bachelor's or Master's degree in Science, Engineering, or a related field.
- At least five years of experience in medical device Quality or Design Assurance, preferably with Class III devices.
- Availability to travel when required.
Preferred Qualifications:
- Certified lead auditor.
- Experience with statistics and test method validation.
- Experience preparing technical documentation for regulatory submissions.
Additional Information: The job description may evolve, and additional responsibilities may be assigned. If you have a passion for quality and patient safety, apply today to join the team in Dublin!