Quality Manager

Quality Manager

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.

The Quality Manager ensures the highest standards of product quality, regulatory compliance, and patient safety in the medical devices manufactured in the company. This leadership role oversees the Quality Management System (QMS) in alignment with FDA 21 CFR Part 820, ISO 13485 and other global regulations. The ideal candidate will drive continuous improvement, risk mitigation, and cross-functional collaboration to maintain excellence in a fast-paced, innovative environment.

Responsibilities :

• Development and implementation of the quality standards, management systems, and policy & procedures.
• Lead the Quality Management System to ensure the continuous improvement business model is achieved, including the development of supporting Standards and Procedures and maintenance of all related documentation.
• Report to top management on the performance of the Quality Management System and areas for improvement.
• Drive Quality objectives, targets, aspects, and programs locally, participate in global quality projects as required.
• Ensure the effectiveness of the Quality Management System through Quality Management Reviews.
• Update / control / maintain Quality related documents and record. Schedule and manage all Quality-related audits, coordinate with all Departments and HQ as required (i.e. Internal, ISO, Safety). Analyze and interpret audit results and introduce and control resulting actions required.
• Conduct Quality related orientations and training to all level employees; Strive to instill and continually improve Quality assurance mindset within the company culture.
• Drive Non-conformance process, Corrective Action process, and improvement process; follow up with the action items and ensure they are closed out in a timely manner.
• Oversee Engineering Change process and support production and process engineering departments in Quality-related matters.
• Promote use of process approach and risk-based thinking among the organization.
• Summarize process improvement measures from above activities and drive continuous process improvement.
• Conduct training in Quality subjects, Supplier initial evaluation and annual evaluation approval, Support software validation.
• Oversee and manage the safety, ESH, for the organization within North America.

Requirements :

The successful candidate should have the minimum qualifications and / or skills :

Bachelors degree or above in engineering or science or closely related field

A minimum of 2 years QE experience in medical devices, automobile or other mechanical and electrical industries or 5 years of experience in other field of quality management in positions of progressing experience.

Familiar with FDA medical device regulations required; RSO certification strongly preferred

Experience in project management (preferred), PMIP certification a plus

Experience related to managing all aspects related to Q & EHS across business areas (including office, manufacturing / production facility, maintenance workshop and field operations) is required.

Quality Management Systems Auditing and Internal Auditor Designations (ISO 13485 : 2016, 21 CFR 820, MDD / MDR)

Strong computer skills including Microsoft Excel, Word, and Outlook.

Candidate must have knowledge of federal, provincial and local EHS regulations.

Experience in a production environment and with a large population of remote workers required.

Bilingual in Chinese is a plus.

Excellent ability to multitask, attention to detail, and organizational skills

Strong analytical skills, proactive and problem-solving mindset

Excellent internal and external customer relations skills.

Work independently, as well as within a team, in a fast paced, customer service driven team environment. Strong English communication skills, both written and verbal

Proven ability to influence and motivate employees, management and contractors to meet the company goals.

Strong organizational skills, the ability to multi-task and handle multiple priorities and changes with professionalism.

Adapt to frequently changing schedules and tight timelines.

Leads by example, demonstrates a positive attitude.

United Imaging is an Equal Opportunity Employer. Diversity, equity, and inclusion matter. United Imaging provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type with regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.