Senior Design Quality Assurance Engineer

• Innovative Medical Device Company: Join a leading company specializing in cutting-edge medical devices for interventional cardiology.
• Global Presence: Be part of a company with a strong international footprint, offering opportunities for global collaboration and growth.
• Commitment to Quality: Work in an environment dedicated to patient safety and product quality, maintaining high standards and effective quality systems.

• Lead Design Quality Projects: As a Senior Design Quality Assurance Engineer, you will lead projects related to the drug-coated balloon product line, ensuring compliance with all internal and regulatory requirements.
• Supervision and Mentoring: Provide coaching and mentoring support within your reporting structure, including assignment and oversight of small to medium projects within the sustaining organization.
• Ensure Compliance: Maintain regulatory compliance with appropriate guidance documents such as company SOP/WI's and EU/FDA/Global guidelines.
• Interface with Cross-Functional Teams: Work closely with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, and Operations teams to provide technical and quality systems input.
• Problem-Solving and Decision-Making: Draw conclusions and make decisions from test data using excellent analytical and problem-solving abilities.
• Support Regulatory Audits: Support internal and external regulatory audits as required.
• Post Market Surveillance: Provide support and direction for post market surveillance activities, such as Field Signal Evaluations, assessment of field product performance, NCEPs, Periodic Safety Update Reports (PSURs), and Q&A from regulatory authorities.

• Educational Background: NFQ Level 8 qualification in a STEM discipline.
• Industry Experience: Minimum of 6 years' industry experience; Design Assurance experience is preferable.
• Technical Expertise: Experience in design control, risk management, design change, and standards compliance (to regulatory requirements).
• Leadership Skills: Strong leadership, problem-solving, technical capabilities, communication, and collaboration skills.
• Team Collaboration: Proven ability to work well both as part of a team and individually.
• Motivation and Enthusiasm: Enthusiastic and fully motivated to develop your career, demonstrate best practices, and drive improvements in product and process quality.
• Coaching and Development: Interested in coaching and developing team members.

• Competitive Salary: Attractive compensation package based on experience and qualifications.
• Career Development: Opportunities for professional growth and career advancement within a dynamic and innovative company.
• Comprehensive Benefits: Including health insurance, retirement plans, and other employee benefits.
• Challenging Work Environment: Work on cutting-edge projects in a supportive and collaborative environment.

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