Quality Engineer Manager

Job Purpose:

The Quality Engineer Manager at PRECISION MEDICAL TECHNOLOGIES is responsible for overseeing the quality engineering team to ensure that all products meet the highest standards of quality and compliance. This role involves developing and implementing quality assurance strategies, managing quality control processes, and leading continuous improvement initiatives to enhance product reliability and performance.

• Lead and manage the quality engineering team, providing guidance, training, and support to ensure team effectiveness and professional growth.
• Develop and implement comprehensive quality assurance strategies and processes to ensure product compliance with industry standards and regulatory requirements.
• Oversee quality control processes, including inspections, testing, and audits, to identify areas for improvement and ensure product quality.
• Collaborate with cross-functional teams, including R&D, manufacturing, and supply chain, to integrate quality standards into product development and production processes.
• Analyze quality data and metrics to identify trends, root causes of issues, and opportunities for process improvements.
• Lead continuous improvement initiatives to enhance product quality, reduce defects, and increase operational efficiency.
• Ensure compliance with relevant regulatory standards and maintain up-to-date knowledge of industry best practices and technological advancements.
• Prepare and present detailed reports on quality performance, issues, and improvement plans to senior management.
• Manage customer complaints and feedback, ensuring timely resolution and implementing corrective actions to prevent recurrence.
• Foster a culture of quality and continuous improvement throughout the organization.

Bachelor’s degree in Engineering, Quality Management, or a related field; or equivalent combination of education and relevant experience.

• Minimum of 5 years of experience in quality engineering within the medical device or healthcare industry.
• Proven experience in a managerial or supervisory role overseeing quality assurance teams.
• Demonstrated experience with regulatory standards such as ISO 13485, FDA regulations, and other relevant quality management systems.

• Strong analytical skills with the ability to interpret complex data and make informed decisions.
• Excellent leadership and team management skills, with the ability to motivate and guide a team towards achieving quality objectives.
• Proficient in the use of quality management software and tools.
• Exceptional communication and interpersonal skills, capable of effectively interacting with cross-functional teams and stakeholders.
• Strong problem-solving abilities with a proactive approach to identifying and resolving quality issues.
• In-depth knowledge of risk management and quality improvement methodologies.
• Ability to develop and implement quality assurance strategies and processes to enhance product reliability and compliance.