Overview
QMS Specialist – Management Controls and QAD Compliance Program Jobs in Lakewood, Colorado, USA at Terumo Blood and Cell Technologies
Position: Global QMS Specialist – Management Controls and QAD Compliance Program
Requisition : 33316
At Terumo Blood and Cell Technologies, our 7,000+ global associates are proud to come to work each day, knowing that what we do impacts the lives of patients around the world.
For Terumo, for Everyone, Everywhere.
We make medical devices and related products that are used to collect, separate, manufacture, and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.
Advancing healthcare with heart.
As a Global Quality Management System (QMS) Specialist
, you’ll play a critical role in ensuring excellence in quality systems and regulatory compliance. This position involves collaborating with cross-functional and international teams to standardize processes, manage global QMS projects, and enhance quality metrics reporting. You’ll also assist with inspections, audits, and document management while ensuring compliance with ISO and FDA regulations, and other global standards.
ESSENTIAL DUTIES
Works closely with cross-functional teams to ensure consistency in quality management processes, drive continuous improvement, and support global regulatory compliance efforts.
Collaborates with global teams to drive standardization of procedures and policies across sites.
Support global regulatory inspections and audits (external and internal) as requested.
Assist with the creation and revision of QMS documents (includes but not limited to Policies, Standard Operating Procedures, Work Instructions) in accordance with internal requirements and industry best practices.
Act as the liaison between TBCT Global Quality in the US and the corporate Quality Assurance Department (QAD).
Is the primary project manager for TBCT global quality projects and coordination.
MINIMUM QUALIFICATION REQUIREMENTS
Education
Bachelor’s degree or equivalent experience in quality systems, regulatory compliance, and project management.
Experience
Minimum 4 years experience.
Strong project management and coordination.
A strong working knowledge of QMS as it relates to 21 CFR Part 820 and ISO 13485.
Experience in a manufacturing environment preferred.
Skills
Demonstrated ability to routinely diagnose problems and recommend solutions through teamwork and other analytical techniques.
Knowledge of international standards and regulations, including ISO 9001, ISO 13485, FDA regulations, and other regional standards.
Experience in the medical device, pharmaceuticals, or manufacturing industries.
Demonstrated ability to communicate effectively both verbally and in writing.
Strong ability to adapt to changing global regulations and business needs.
LOCATION
Lakewood, Colorado – Open to candidates willing to relocate to the area.
PHYSICAL REQUIREMENTS
Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Target Pay Range: $86,000.00 to $ – Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant.
We are proud to be an Equal Opportunity Affirmative Action Employer.
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Title: QMS Specialist – Management Controls and QAD Compliance Program
Company: Terumo Blood and Cell Technologies
Location: Lakewood, Colorado, USA
Category: Quality Assurance – QA/QC, Healthcare
