Quality Management Manager

United Imaging

Location: On-site Houston, Tx | Classification: Full-Time

Who we are?

United Imaging is a leading global medical device developer and supplier with a diversified portfolio of advanced medical products, digital healthcare solutions, and intelligent solutions that cover the entire process of imaging diagnosis and treatment. From our North American HQ in Houston, we are passionate about expanding our customer sales and support structure, embracing the highest quality and craftsmanship in each of our medical imaging products, and dedicated to building an outstanding organization.

Join our innovative team with the mission of developing and supplying advanced technologies and improving patient care worldwide. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Company Page: http://www.united-imaging.com/en/home/

Benefits

When joining our team, we offer the following benefits: medical, dental, vision, short- & long-term disability insurance, employee assistance program, company paid basic life insurance, 401(k) with employer match, paid time off, sick leave, and (11) paid holidays. Compensation decisions are based upon the candidate level of skill, qualifications, geographical location and experience, and it is not typical for an individual to be hired at or near the top of the posted pay range. Additionally, the position may also be eligible to earn performance-based incentive compensation (such as cash bonuses).

Job Summary

The Quality Management Manager is responsible for leading the development and implementation of robust quality systems and procedures to ensure the consistent delivery of high-quality products. This role involves overseeing the complaint handling process, monitoring product quality, and collaborating with internal and external stakeholders to ensure regulatory compliance. With a focus on continuous improvement, the Quality Management Manager provides strategic leadership in all quality and regulatory matters, driving excellence throughout the organization's operations.

Duties & Responsibilities

• Establishment of Quality Systems and Procedures: Develop and implement comprehensive quality systems and procedures throughout the organization to ensure compliance with industry standards and regulations.
• Ensuring High Quality Products: Implement and oversee stable processes, effective quality control methods, and inspection protocols (including incoming, in-process, and final inspections) to maintain the consistent production of high-quality products.
• Complaint Handling Process: Lead the design, implementation, and oversight of the complaint handling process, ensuring prompt resolution and appropriate actions are taken to address customer feedback.
• Overseeing Complaints: Manage all complaints received, making informed decisions on necessary actions, including reporting complaints in accordance with regulatory requirements.
• Monitoring Product Quality: Continuously monitor product quality, initiate investigations as needed, and drive corrective and preventive actions to uphold and enhance quality standards.
• Collaboration with UIH HQ QM: Foster collaboration and communication with the UIH HQ Quality Management team to ensure alignment with global quality standards and regulatory compliance.
• Leadership in Quality and Regulatory Matters: Provide strategic leadership and guidance on all quality and regulatory matters, ensuring compliance with FDA regulations and other relevant standards.

Note: This job description is intended to outline the primary duties and requirements of the role and may be adjusted as needed to meet the evolving needs of the organization

• Minimum of 5 years of experience in healthcare quality and regulatory roles, demonstrating a strong understanding of Quality Management systems and regulatory requirements.
• Proven experience with FDA regulations and reporting requirements.
• Fluent spoken and written communication skills in both English and Chinese would be advantageous.