QMS Engineer at United Imaging Healthcare North America LLC

Houston, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

18 Mar, 26

Salary

0.0

Posted On

18 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Supplier Evaluation, Quality Audits, Document Control, Change Management, Regulatory Compliance, CAPA, NCR, Risk Management, Internal Auditing, Communication Skills, Analytical Skills, Problem-Solving, Root Cause Analysis, ISO 13485, FDA CFR820, Quality Assurance

Industry

Medical Equipment Manufacturing

Description

Description 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 (12) 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 bonus(es). Duties & Responsibilities Supplier Evaluation & Selection: Co-work with buyers and technical team (HQ) to perform the new supplier evaluation, perform quality audits to make sure the supplier’s quality system is effective before use for production. Review purchasing technical documents, and verification documents (i.e. Quality Agreements). Develop, implement, and maintain supplier quality agreements to ensure compliance with medical device standards and regulations (e.g., ISO 13485, FDA CFR820) in coordination with Corporate SQM. Work in coordination with HQ PMS (Post Market Surveillance) team, performing initial analysis on potential customer complaints. Experience with QMS (Document Control System, Change Management) Manage the life cycle of controlled documents in the electronic or Manual document management system (document creation, revision, archival, retention and withdrawal/retirement) Support regulatory registrations and submissions Support radiation safety state registration, as well as registration submissions Support CAPA, NCR, Deviation, quality training, Risk Management, and other quality functions as needed. Review records to ensure compliance with applicable SOPs, FDA & ISO requirements, accreditation standards, and regulations Additional Supporting Responsibilities: As an internal auditor to conduct the internal audit. Support for the external audit. Other support related to QMS/Compliance quality. Requirements Bachelor’s degree in engineering, Supply Chain, or related field (master’s degree will be a plus). 2+ years of experience as QE/SQE, or 3+ years of experience in quality assurance, preferably within the medical devices industry. Excellent analytical and problem-solving skills, with proficiency in root cause analysis tools (e.g., 8D, 5 Whys, SPC, PFMEA). Experience with medical device regulatory requirements, standards, and quality systems (e.g., ISO 13485, FDA CFR820, MDR). Effective communication and interpersonal skills to work with suppliers and internal teams. Preferred Skills: ISO 13485 internal Auditor certification (lead Auditor will be a plus). Experience managing QMS in the medical device industries. Certifications such as CQE (Certified Quality Engineer) or Six Sigma Green/Black Belt are a plus. Working Conditions: Magnetic Environment Exposure: This position requires working in an environment where strong magnetic fields may be present. Employees may be exposed to powerful magnets, electromagnetic equipment, or other devices that generate magnetic fields. Risk to Ferrous Metals in the Body: Due to the nature of the magnetic environment, employees must not wear or carry ferrous metals on their person while in the designated work area. This includes, but is not limited to, metal objects such as steel, iron, and other ferrous materials. Additionally, employees with implants, medical devices, or foreign objects containing ferrous metals within their body (e.g., certain surgical implants, pacemakers, or metal pins) may be at risk and must disclose any such conditions to their supervisor prior to starting work. Diversity, Equity, and Inclusion 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.

Responsibilities

The QMS Engineer will evaluate and select suppliers, perform quality audits, and develop supplier quality agreements to ensure compliance with medical device standards. Additionally, they will manage controlled documents and support regulatory registrations and submissions.