Quality Assurance Engineering (QA/QE) Specialist - Biointellisense Inc.

What you will be doing

• Responsible for supporting the operation, maintenance, and improvement of the Quality Management System modules including but not limiting to Document Control, Complaint Handling, Audit Program, and Corrective Action and Preventive Action (CAPA).

• Quality Management System (QMS):
• Support the maintenance of the QMS and compliance with FDA and international regulatory requirements (e.g. ISO 13485).
• Conduct internal audits to evaluate and improve adherence to the QMS processes.

• Quality Processes:
• Identify opportunities for process improvement and drive initiatives to enhance product quality, reduce defects, and streamline operations.
• Implement best practices and tools for process control and improvement.
• Own individual CAPAs, drive and follow through CAPA investigations and actions with other teams.

• Documentation and Record Keeping:
• Input and update documents and records using electronic QMS software.
• Maintain accurate and organized records of quality documentation, including design and development, validation, calibration, change control, and customer feedback.

• Customer Feedback and Complaint Management:
• Investigate and analyze customer complaints, working closely with other departments to determine root causes.
• Implement corrective and preventive actions to address identified issues and prevent recurrence.
• Use customer feedback data to drive continuous improvement in product quality and customer satisfaction.
• Maintain risk assessment and risk management files.

• Other
• Other duties as required by the Quality & Regulatory Team.

What you need

• Required:
• Bachelor's degree in biomedical engineering, other engineering areas, or technology and science.
• Minimum 2 years working or project experience in Quality Assurance, Quality Engineering, process Improvement or similar discipline.
• Experience in FDA regulations and ISO 13485 requirements pertaining to medical devices.
• Experience and working knowledge of eQMS software (examples: Greenlight Guru, Master Control).
• Excellent communication, teamwork, and problem-solving skills.
• Proficiency in Microsoft Office Suite, particularly Excel for data management and analysis.
• Ability to learn and adapt to new software and technologies quickly.

• Preferred:
• Experience in software validation
• Experience in risk management activities
• Basic understanding of data analysis tools and techniques.

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