Riverpoint Medical · 4 days ago
Quality Systems Specialist II
Portland, OR
Full-time
Onsite
Mid Level
3+ years expRiverpoint Medical is a company specializing in the design and manufacturing of premium medical devices. The Quality Systems Specialist II will maintain and improve the Quality Management System by ensuring compliance with regulatory requirements and internal policies, overseeing training system effectiveness, and supporting audit preparation among other critical quality functions.
BiotechnologyHealth CareManufacturingMedical Device
Hiring Manager
Jan Turin
Responsibilities
Ensures the effectiveness of the training program, including onboarding activities, training records management, and competency tracking
Monitors training system compliance and provides recommendations for improvements
Provides oversight for the development, implementation, and maintenance of quality programs, systems, processes, and procedures to ensure compliance with internal policies and external regulatory standards
Assists in evaluating and improving QMS processes, supporting continuous improvement initiatives
Ensures quality assurance programs and policies are maintained, updated, and aligned with evolving regulatory expectations
Supports audit and inspection readiness, including preparation, execution, and post-audit activities
Assists with internal and external audits, facilitates corrective actions, and ensures timely resolution of findings
Serves as a point of contact for regulatory and customer audits, providing documentation and addressing auditor inquiries
Prepares reports and documentation related to audits, Quality Management Reviews (QMR), and Corrective and Preventive Actions (CAPA)
Collects, analyzes, and presents key quality metrics and trends to leadership during QMR meetings
Provides oversight to systems related to change management, nonconformances, deviations, quality alerts, CAPAs and other quality systems
Monitors CAPA effectiveness, ensuring continuous improvement of quality processes
Ensures the quality assurance programs and policies are maintained and modified regularly
Provides expertise and guidance in interpreting regulatory and compliance requirements to support company policies
Works collaboratively with cross-functional teams to drive quality culture and compliance awareness
Additional responsibilities may be assigned at the manager’s discretion
Qualification
Required
Bachelors Degree with 3+ years of work experience, preferable in the manufacturing of medical devices
Ability to read and understand documentation relating to the Quality Management System
Effective oral and written communication skills in English
Computer skills, including Word and Excel
Preferred
Previous QC experience
Benefits
Medical, Dental and Vision
Life and Accidental Death Insurance
401(k) with company match and immediate vesting
Paid Time Off
8 company paid holidays
Referral Bonus
Annual Bonus
Company
Riverpoint Medical
Riverpoint Medical is a manufacturing company.
201-500 employees
H1B Sponsorship
Riverpoint Medical 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 (1)
2023 (1)
2022 (1)
Funding
Current Stage
Growth StageTotal Funding
unknown2019-06-28Acquired
Leadership Team
D
Doug King
Chief Executive Officer
Recent News
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2025-05-06
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