UST
Website:
ust.com
Job details:
Role Description
Associate II - Engineering Design
Who We Are
At UST, we help the world’s best organizations grow and succeed through transformation. Bringing together the right talent, tools, and ideas, we work with our client to co-create lasting change. Together, with over 26,000 employees in 25 countries, we build for boundless impact—touching billions of lives in the process. Visit us at .
Job Summary
The IT QMS and Training Specialist i responsible for supporting and maintaining the IT Quality Management System (QMS) and associated training programs to ensure compliance with applicable regulations, standards, and internal procedures. This role partners closely with IT, Quality, and business stakeholders to ensure IT processes, systems, and personnel meet regulatory and organizational requirements.
Key Responsibilities
IT Quality Management System (QMS)
- Support the development, implementation, and maintenance of IT QMS processes, procedures, and documentation.
- Ensure IT policies, SOPs, templates, and work instructions align with regulatory requirements (e.g., FDA, ISO 13485, ISO 27001, GxP, as applicable).
- Manage controlled documents within the electronic QMS (eQMS), including document lifecycle activities (authoring, review, approval, revision, and retirement).
- Support IT audits, inspections, and assessments by preparing documentation, responding to auditor questions, and tracking corrective actions.
- Collaborate with IT and Quality teams to ensure validation and qualification deliverables align with QMS requirements.
- Track and support CAPAs, deviations, and change management activities related to IT systems and processes.
Training Management
- Create and administer the Training Matrix, IT training program and Learning Management System (LMS), ensuring accuracy and compliance.
- Coordinate onboarding and role‑based training for IT personnel and system users.
- Assign, monitor, and report on required and recurring training.
- Ensure training content is current, effective, and aligned with QMS documents and system use.
- Support training effectiveness assessments and audit readiness.
Cross‑Functional Collaboration
- Act as a liaison between IT, Quality, and business stakeholders.
- Provide guidance to IT teams on QMS and training requirements.
- Support SaaS/vendor oversight activities as they relate to IT quality and training expectations.
Continuous Improvement
- Identify opportunities to improve IT QMS efficiency, documentation clarity, and training effectiveness.
- Support QMS metrics, reporting, and trending activities.
- Assist with process harmonization and standardization initiatives.
Required Qualifications
- Bachelor’s degree in Information Technology, Computer Science, Quality, Life Sciences, or a related field (or equivalent experience).
- 3+ years of experience in IT Quality, QMS, Compliance, and/or Training in a regulated environment.
- Hands‑on experience with eQMS and LMS platforms.
- Strong understanding of IT controls, system documentation, and regulated and non-regulated environments.
- Experience supporting audits and inspections.
- Excellent written and verbal communication skills.
Preferred Qualifications
- Experience in medical device, pharmaceutical or biotech.
- Knowledge of FDA QSR, ISO 13485, GxP, ISO 27001 and GxP.
- Experience with system validation/qualification (IQ/OQ/PQ).
- Risk‑based thinking
- Continuous improvement mindset
What We Believe
We’re proud to embrace the same values that have shaped UST since the beginning. Since day one, we’ve been building enduring relationships and a culture of integrity. And today, it's those same values that are inspiring us to encourage innovation from everyone, to champion diversity and inclusion and to place people at the center of everything we do.
Humility
We will listen, learn, be empathetic and help selflessly in our interactions with everyone.
Humanity
Through business, we will better the lives of those less fortunate than ourselves.
Integrity
We honor our commitments and act with responsibility in all our relationships.
Equal Employment Opportunity Statement
UST is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation
All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
UST reserves the right to periodically redefine your roles and responsibilities based on the requirements of the organization and/or your performance.
- To support and promote the values of UST.
- Comply with all Company policies and procedures
Skills
engineering design,qms,it quality management system,eqms,
Click on Apply to know more.