Advanced Sterilization Products · 18 hours ago
Global Quality Systems Specialist
United States
Full-time
Remote
Mid Level
$71K/yr - $118K/yr
3+ years expAdvanced Sterilization Products is a leading global provider of innovative sterilization and disinfection solutions. The Global Quality Systems Specialist is responsible for executing global Quality System requirements, managing document revisions, coordinating change control documentation, and supporting quality planning activities.
Health CareMedicalMedical Device
Responsibilities
Manages document revisions, ensures compliance with formatting and approval workflows
Coordinate change control documentation and facilitate cross functional review
Analyzes change orders to ensure compliance to GDP requirements and existing procedures
Track and monitor quality systems metrics, including but not limited to: IE, CAPA and NC
Support timely documentation and closure
Assist in quality planning activities and QMS review preparation
Manage training assignments and monitor training metrics
Participate in internal audits and support audit readiness activities
Support internal audit logistics such as scheduling
Provide informal guidance to new team members
Solves problems in straightforward situations; analyzes possible solutions using technical experience and judgment and precedents
Explains complex information to others in straightforward situations
Collaborate with cross-functional teams to resolve issues
Collaborate cross functionally to support projects as assigned by direct manager
Responsible for communicating business related issues or opportunities to next management level
Supports continuous improvement initiatives
Perform other duties as assigned
Qualification
Required
Working knowledge of quality management systems and experience with ISO 13485
Excellent written and verbal communication skills (English)
Demonstrated ability to train, mentor, and coordinate the work of others in daily operations
Seeks to deeply understand customer needs and prioritize work accordingly
Willing to take on the unknown and overcome adversity to support the goals of the business
Seeks varied perspectives and experiments with new ways of solving problems
Collaborates in support on team's success
Demonstrates urgency and ownership to consistently deliver on objectives using FBS
Bachelor's degree in engineering, science, or related field
Minimum 3 years of experience in a quality or regulatory role in medical devices or related regulated industry
Equivalent combination of education and experience will be considered
Benefits
This position is also eligible for bonus as part of the total compensation package.
Company
Advanced Sterilization Products
In healthcare, nothing is more important than protecting patients.
1001-5000 employees
H1B Sponsorship
Advanced Sterilization Products has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (5)
2023 (1)
2022 (1)
2021 (3)
2020 (3)
Funding
Current Stage
Late StageTotal Funding
unknown2018-06-06Acquired
Leadership Team
Ivan Salgo
Chief Medical Officer & Vice President - ASP/Fortive
Estelle Pellegrino
Sr Human Resources Business Partner
Recent News
2025-10-06
2025-08-08
Company data provided by crunchbase