Quality Systems Subject Matter Expert
Overview Born digital, UST transforms lives through the power of technology. We walk alongside our clients and partners, embedding innovation and agility into everything they do. We help them create transformative experiences and human-centered solutions for a better world.
Role Description Quality Systems Subject Matter Expert
Lead I - Internal Audit
You Are UST is searching for a Quality Systems Subject Matter Expert focused on process ownership.
The Opportunity Training
Document management
Change control
Quality system process design and implementation.
This position description identifies the responsibilities and tasks typically associated with the performance of the position. Other relevant essential functions may be required.
What You Need 8–12+ years of experience in Quality Systems (QMS) within MedTech, Pharma, or regulated life sciences
5+ years as a process owner, not merely a contributor, for one or more of the following:
Change Control
Training systems
Document Management Systems (DMS)
Non-conformance management and/or quality metrics
Demonstrated experience designing, implementing, and governing QMS processes end-to-end (not just executing transactions)
Required: Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related technical discipline
Preferred: Master's degree (Quality, Engineering, Regulatory, or related)
Formal Quality training or certifications (e.g., ISO 13485, CQE, CQA) are a plus but not substitutes for hands-on process ownership
Core Quality Systems Expertise (Must Have)
Deep understanding of Quality Systems, specifically:
Training lifecycle management
Change Control governance
Document management and document lifecycle control
Non conformance handling and quality metrics
Strong focus on process design, implementation, and continuous improvement
Experience defining
SOPs and work instructions
Governance models
Roles and responsibilities
Metrics and effectiveness monitoring
Compensation can differ depending on factors including but not limited to the specific office location, role, skill set, education, and level of experience. UST provides a reasonable range of compensation for roles that may be hired in various U.S. markets as set forth below.
Role Location: Remote-US
Compensation Range : $72,000-$108,000
Benefits Full-time, regular employees accrue a minimum of 10 days of paid vacation per year, receive 6 days of paid sick leave each year (pro-rated for new hires throughout the year), 10 paid holidays, and are eligible for paid bereavement leave and jury duty. They are eligible to participate in the Company's 401(k) Retirement Plan with employer matching. They and their dependents residing in the US are eligible for medical, dental, and vision insurance, as well as the following Company-paid Employee Only benefits: basic life insurance, accidental death and disability insurance, and short- and long-term disability benefits. Regular employees may purchase additional voluntary short-term disability benefits, and participate in a Health Savings Account (HSA) as well as a Flexible Spending Account (FSA) for healthcare, dependent child care, and/or commuting expenses as allowable under IRS guidelines. Benefits offerings vary in Puerto Rico.
Part-time employees receive 6 days of paid sick leave each year (pro-rated for new hires throughout the year) and are eligible to participate in the Company's 401(k) Retirement Plan with employer matching.
Full-time temporary employees receive 6 days of paid sick leave each year (pro-rated for new hires throughout the year) and are eligible to participate in the Company's 401(k) program with employer matching. They and their dependents residing in the US are eligible for medical, dental, and vision insurance.
Part-time temporary employees receive 6 days of paid sick leave each year (pro-rated for new hires throughout the year).
All US employees who work in a state or locality with more generous paid sick leave benefits than specified here will receive the benefit of those sick leave laws.
What We Believe We proudly embrace the values that have shaped UST since day one. We build our culture of Humility, Humanity, and Integrity. These values inspire us to nurture a people-first, human centric culture that fosters diversity, prioritizes sustainable solutions, and keeps our people and clients at the forefront of all decisions.
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.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other applicable characteristics protected by law. We will consider qualified applicants with arrest or conviction records in accordance with state and local laws and "fair chance" ordinances.
UST reserves the right to periodically redefine your roles and responsibilities based on the requirements of the organization and/or your performance.
UST
CB
Skills quality audit,change control,process ownership,windchill,document management,training systems,quality systems,process implementation,quality metrics
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