Quality Assurance Director- Healthcare jobs in Houston, TX

Applied Optoelectronics, Inc. (AOI) is a leading provider of advanced optical networking and communication solutions. With a focus on innovation and reliability, we design and manufacture high-performance optoelectronic components and modules for applications in data centers, telecommunications, and beyond. As we continue to grow and expand our product offerings, we are seeking a talented and experienced individual to join our team as Director of Quality Assurance.

Summary

As the Director of Quality Assurance at Applied Optoelectronics, Inc., you will be responsible for leading our efforts to ensure the highest levels of product quality and reliability. Reporting directly to the executive management team, you will oversee all aspects of quality management, including establishing and maintaining quality systems, driving continuous improvement initiatives, and fostering a culture of quality excellence throughout the organization. Key responsibilities include:

Quality Management System (QMS) Development and Maintenance

• Develop, implement, and maintain a robust Quality Management System (QMS) that aligns with industry standards and regulatory requirements.
• Establish quality policies, procedures, and guidelines to govern all aspects of our operations, from product design and development to manufacturing and customer support.
• Conduct regular audits and assessments to evaluate the effectiveness of the QMS and identify opportunities for improvement.

Product Quality Assurance

• Oversee the entire product lifecycle, from initial design and development through production and delivery, to ensure that products meet or exceed customer expectations for quality and reliability.
• Work closely with cross-functional teams, including engineering, manufacturing, and supply chain, to integrate quality principles into all stages of product development and production processes.
• Implement robust quality control measures, including incoming inspection, in-process testing, and final product validation, to detect and address any deviations from quality standards.

Supplier Quality Management

• Collaborate with the procurement team to evaluate and qualify suppliers based on their ability to meet our quality requirements and standards.
• Establish and maintain strong relationships with key suppliers, and work together to address quality issues and drive continuous improvement initiatives.
• Conduct regular supplier audits and performance evaluations to ensure ongoing compliance and identify areas for enhancement.

Regulatory Compliance

• Stay informed of relevant industry regulations, standards, and certifications, and ensure that our products and processes remain in compliance with all applicable requirements.
• Lead efforts to obtain and maintain necessary certifications and approvals, such as ISO 9001, ISO 13485, and industry-specific certifications as applicable.

Continuous Improvement and Quality Excellence

• Champion a culture of continuous improvement and quality excellence throughout the organization, fostering a mindset of accountability and ownership for quality outcomes.
• Utilize data-driven approaches, such as statistical analysis and Six Sigma methodologies, to identify root causes of quality issues and implement corrective and preventive actions.
• Drive initiatives to optimize processes, reduce waste, and enhance overall operational efficiency, with a focus on delivering value to our customers.

Qualifications

• Bachelor's degree in Engineering, Quality Management, or a related field; advanced degree preferred.
• Minimum of 10 years of experience in quality management roles within the optoelectronics industry or a related field.
• Proven track record of successfully implementing and managing Quality Management Systems (QMS), preferably in compliance with ISO standards.
• Strong understanding of relevant quality regulations, standards, and certifications, such as ISO 9001, ISO 13485, FDA QSR, RoHS, and REACH.
• Experience with quality tools and methodologies, such as statistical process control (SPC), Failure Mode and Effects Analysis (FMEA), and root cause analysis (RCA).
• Excellent leadership and communication skills, with the ability to influence and collaborate effectively across all levels of the organization.
• Demonstrated ability to drive continuous improvement initiatives and lead cross-functional teams to achieve quality objectives.
• Certified Quality Engineer (CQE), Certified Quality Manager (CQM), or similar certifications are a plus.
• Bilingual Mandarin Chinese is required.

Location

This position will be full time and on-site at our Sugar Land, Texas location.

Why AOI?

In addition to competitive salary, AOI offers

• Flexible and competitive health (medical, dental, vision) plans offer the employee with the right options to meet individual and family needs.
• Employer matching on 401(k) deferrals.
• Generous PTO policy, with unused PTO payout at end of the year.
• Relocation package available within US.
• Immigration sponsorships (Must be currently authorized to work in the US).

Join Applied Optoelectronics, Inc. and play a key role in shaping the future of optical networking and communication technology. If you are passionate about quality excellence and thrive in a dynamic, fast-paced environment, we invite you to apply for the position of Director of Quality Assurance and contribute to our continued success. Apply now and be part of our journey towards delivering innovative solutions that power the world's connectivity.

#QA!