Key Responsibilities
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* Collaborate cross-functionally with other departments to promote the achievement of health and safety goals.
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* Deliver on Key Performance Indicators (KPIs) that support business objectives.
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* Develop and continuously improve the Quality Management System, ensuring compliance with regulatory requirements.
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* Maintain accurate documentation to comply with quality standards and customer requirements.
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* Provide quality guidance to the team for day-to-day deliverables.
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* Develop strong relationships with customer organizations and other project stakeholders.
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* Identify and initiate projects to ensure continuous improvement.
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* Quality review of responsible area validation documentation.
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* Investigate root causes and implement effective corrective actions to prevent re-occurrence of issues.
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* Maintain production Good Manufacturing Practices (GMP) standards and compliance; establish inspection standards, sampling plans and test methods where applicable.
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* Prepare and update procedures and associated documentation.
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* Support customer audits and surveillance/accreditation audits.
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* Conduct and drive audits to ensure compliance with ISO 13485.
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* Contribute to quality planning and new product introductions from a quality perspective.
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Requirements
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* A degree in Quality or a relevant Science/Engineering field is required.
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* Minimum of 2 years of industry experience is necessary.
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* Working knowledge of FDA/ISO/MDD Quality systems for Medical Device companies is essential.
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* Experience in a similar role as Quality Engineer is advantageous.
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* Quality experience in component and device manufacturing is desirable.
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* Excellent written and oral communication skills are crucial.
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About Us
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We are a global industrial technology leader dedicated to creating a safer, sustainable, productive, and connected future.
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Our broad range of connectivity and sensor solutions enable the distribution of power, signal and data to advance next-generation transportation, energy networks, automated factories, data centers, medical technology and more.
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With over 85,000 employees, including 9,000 engineers, working alongside customers in approximately 130 countries, we ensure that every connection counts.
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Learn more at te.com/careers.