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Position Overview

We are currently accepting applications for the role of Quality System Engineer. The successful candidate will be tasked with developing implementing and maintaining quality management systems to ensure compliance with industry standards and regulatory requirements. This position will require collaboration with cross-functional teams to identify opportunities for improvement and promote continuous improvement initiatives throughout the organization.

Key Responsibilities

• Design and oversee quality control processes and documentation to ensure accurate and consistent procedures are followed.
• Monitor and report on system performance track quality metrics and ensure ongoing compliance with relevant standards.
• Conduct internal and external audits and support the implementation of corrective and preventive actions to address identified issues.
• Provide training and guidance to staff on quality system protocols fostering a culture of quality throughout the team.
• Work closely with engineering manufacturing and regulatory teams to ensure the seamless integration of quality standards across departments.
• Design and oversee quality processes and documentation to ensure accurate and consistent procedures are followed.
• Monitor and report on system performance track quality metrics and ensure ongoing compliance with relevant standards.
• Participate in internal and external audits and support the implementation of corrective and preventive actions to address identified issues.
• Manage and track Corrective and Preventive Actions (CAPA) and Non-Conformances (NC) ensuring timely resolution and documentation in accordance with regulatory requirements.
• Provide training and guidance to staff on quality system protocols fostering a culture of quality throughout the team.
• Work closely with engineering manufacturing and regulatory teams to ensure the seamless integration of quality standards across departments

Qualifications

• Bachelors degree in engineering Quality Management or a related field.
• At least three years of experience working with quality systems in a regulated industry.
• Comprehensive understanding of ISO FDA or other applicable standards.
• Strong analytical problem-solving and communication skills.
• Certification in quality management such as Six Sigma or CQE is preferred.

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The anticipated base pay range for this position is :

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