RSA Inc. · 4 hours ago
Quality Systems Specialist
Woodinville, WA, Woodinville, WA, US
Full-time
Onsite
Entry, Mid Level
$55K/yr - $60K/yr
2+ years expRSA Inc. is dedicated to ensuring critical medical devices are available for patient treatment and diagnosis. The Quality Systems Specialist will implement and maintain ISO 13485 certified quality management systems, ensuring that products meet quality standards and customer requirements.
Health CareManufacturingMechanical EngineeringMedicalMedical DeviceNetwork HardwareOncology
Responsibilities
Ensure quality procedures are being followed to ensure quality
Revise procedures and documentation as necessary, in accordance with the document change procedure
Assure calibration program is current and maintained
Schedule maintenance, cleaning and calibration for the equipment in the shop to ensure proper operation
Review, coordinate, and close customer feedback (complaints, warranty, DOA’s)
Take appropriate corrective action in accordance with the CAPA process (internal findings, external findings, customer complaints, etc.)
Ensure document control and change management processes are maintained
Ensure all WA DOH requirements are satisfied for use of x-ray equipment
Management of radiation area monitors
Collaborate with procurement to review and approve new vendors
Collaborate with procurement to evaluate the performance of current vendors and maintain vendor certifications, according to our quality procedure
Participate in internal and external audits
Perform final QC inspections of all products going out the door
Perform quarterly ESD and chemical audits
Monitor production methods, product safety/quality, and risk management
Coordinate quality awareness training for personnel
Monitor and maintain site employee training matrix
Monitor customer feedback on trends and opportunities for improvement
Monitor non-conforming products for trends and take corrective action as needed
Participate in regular discussions with the Regulatory Manager to communicate updates, concerns, risks, resource needs, and opportunities for improvement
All other duties as assigned
Qualification
Required
Bachelor's degree in relevant field or an equivalent combination of skills, training, and experience
2+ years of experience with a quality management system
Knowledge and familiarity with ISO 13485 and/or ISO 9001
Good communication and project management skills
Independent thinker and ability to prioritize
Excellent written and verbal communication skills
Ability to work in a team environment as well as independently
Ability to work well in a fast-paced environment while managing multiple projects
Attention to detail and great organizational skills
Ability to lift 75 pounds
Ability to stand for long periods of time
Ability to travel, both domestically and internationally, for extended periods of time
Dexterous ability to manipulate small objects
Willing to work standard and non-standard hours as required to support the customers
Company
RSA Inc.
Patient Focused. Quality Driven.
51-200 employees
H1B Sponsorship
RSA Inc. 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 (8)
2024 (4)
2023 (4)
2021 (6)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Sheridan Capital Partners
2022-06-22Private Equity
Leadership Team
Larry Nguyen
Chief Information Officer
Samantha Honaker Bentley
Human Resources Business Partner
Recent News
Business Wire
2025-06-25
Company data provided by crunchbase