Quality Assurance Manager

We are a leading contract manufacturer specializing in electronics, electro-mechanical products. With a rich history of expertise and a forward-thinking approach, we transform concepts into reality. Our state-of-the-art facilities, seasoned engineers, and unwavering dedication ensure the highest quality across all phases of production. Partner with us to navigate the complexities of manufacturing and bring innovation to every industry we touch.

Job Details:

We are seeking a dynamic and experienced Quality Assurance Manager to join our Engineering team. In this critical role, you will be responsible for managing and maintaining our ISO 9001.2015, ISO13485, ISO 14001, and ISO-27001 certifications, ensuring compliance with FDA regulations, and driving continuous improvement initiatives. You will also be responsible for managing all aspects of quality assurance and control, including electronic and electro-mechanical troubleshooting, analog design, FPGA, VHDL, OPAMP circuits, and root cause analysis.

Responsibilities:

• Manage and maintain our ISO 9001.2015, ISO13485, ISO 14001, and ISO-27001 certifications.
• Ensure compliance with FDA regulations and other relevant industry standards.
• Lead quality assurance and control initiatives, including Six Sigma projects.
• Conduct quality audits and manage corrective and preventive action programs.
• Troubleshoot electronic and electro-mechanical issues, using tools such as oscilloscopes and multimeters.
• Design and implement test instructions for a variety of electrical components, including flip-flop circuits.
• Analyze root causes of product defects and develop strategies to prevent recurrence.
• Manage RMA repair process and ensure customer satisfaction.
• Drive continuous improvement initiatives and foster a culture of excellence in quality.
• Use ERP systems to track and report on quality metrics.

Qualifications:

• Bachelor's degree in Engineering or a related field.
• Certifications in ISO 9001.2015, ISO13485, ISO 14001, and ISO-27001 are PLUS.
• Experience with FDA compliance and Six Sigma methodology.
• Proven experience in electronic and electro-mechanical troubleshooting, analog design, FPGA, VHDL, OPAMP circuits.
• Strong knowledge of electrical components and testing tools such as oscilloscopes and multimeters.
• Experience with ERP systems and RMA repair process.
• Excellent problem-solving skills and ability to conduct root cause analysis.
• Strong leadership and project management skills.
• Commitment to continuous improvement and quality excellence.