QMS Engineer

United Imaging North America•Houston, TX

52d

About The Position

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/ 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).

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.

Nice To Haves

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.

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
As an internal auditor to conduct the internal audit.
Support for the external audit.
Other support related to QMS/Compliance quality.