At Natus, our team is united by a common goal - to enhance the standard of patient care worldwide. We bring together individuals from diverse backgrounds who collaborate to enhance the quality of life for patients globally. Our organization takes a holistic approach, focusing on providing top-notch equipment, support, and education. We are dedicated to excellence, ensuring that our products and team members meet the highest standards.
Natus is renowned for being a leading provider of solutions for screening, diagnosing, and treating disorders that impact the brain, neural pathways, and sensory nervous systems. We are currently seeking new talent to join our dynamic team. If you are passionate about making a difference in people's lives, you could be the perfect addition to our team. Join us at Natus and be a part of our mission to improve patient care worldwide.
The Job: Permanent Contract - Full time (39 Hrs), Monday to Friday
Position Overview: The Design Assurance Engineer is a pivotal role responsible for ensuring that product designs meet rigorous quality and regulatory standards. This position involves working closely with design teams to implement quality assurance processes throughout the product development lifecycle, from initial concept to final production.
Duties and Responsibilities: Quality Assurance Integration: Collaborate with design and development teams to integrate quality assurance processes into product design.Ensure that design outputs meet all regulatory and quality requirements.Conduct risk assessments and implement mitigation strategies to address potential design issues.Develop and maintain risk management files in accordance with regulatory standards.Regulatory Compliance: Ensure product designs comply with applicable regulatory standards (e.g., ISO 13485, FDA QSR, MDR).Prepare and review documentation for regulatory submissions.Design Verification and Validation: Develop and execute design verification and validation plans.Analyze test data and ensure that design specifications are met.Identify opportunities for process improvements and implement best practices in design assurance.Lead root cause analysis and corrective action processes for design-related issues.Supplier Quality Management: Work with suppliers to ensure that components and materials meet quality standards.Conduct supplier audits and manage supplier quality performance.Cross-Functional Collaboration: Collaborate with manufacturing, quality, and regulatory teams to ensure seamless product development.Provide technical support and guidance on quality-related matters.Qualifications and Skills: Bachelor's degree in Engineering, Quality Assurance, or a related field.3-5 years of experience in a quality assurance role, preferably in the medical device industry.Experience with regulatory standards such as ISO 13485, FDA QSR, and MDR.Strong understanding of design controls and risk management principles.Excellent problem-solving and analytical skills.Effective communication and interpersonal skills.Proficiency in quality management systems and tools.ISO Lead Auditor certification or equivalent is a plus.Benefits: A competitive salary package.Comprehensive Healthcare & Life Assurance coverage.Additional benefits such as income protection and death in service benefit.Health & Wellbeing Events.Recognition Scheme.Free Parking.Educational assistance.EEO Statement: Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.
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