Quality Systems Specialist II

Riverpoint Medical; Portland (OR); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental and Vision

Life and Accidental Death Insurance

401(k) with company match

Paid Time Off

Bonus pay

Job summary

A leading medical device manufacturer located in Northeast Portland is hiring a Quality Systems Specialist II. In this role, you'll be integral to maintaining and enhancing the Quality Management System (QMS) to ensure compliance with FDA and ISO standards. Responsibilities include overseeing training effectiveness, managing quality audits, and driving continuous improvement initiatives. You should have a Bachelor's Degree and at least 3 years of relevant experience. The position offers benefits including medical, dental, 401(k), and paid time off.

Qualifications

• 3+ years of experience in the manufacturing of medical devices.
• Ability to read and understand documentation relating to the Quality Management System.

Responsibilities

• Ensure the effectiveness of the training program and track competency.
• Support audit and inspection readiness activities.
• Provide oversight for quality programs and compliance with regulatory standards.
• Analyze key quality metrics and present them during QMR meetings.

Skills

Understanding of FDA CFR 820

ISO 13485 knowledge

Effective oral and written communication skills

Computer skills (Word and Excel)

Education

Bachelor’s Degree

Job description

Job Overview

Riverpoint Medical in Northeast Portland is hiring a Quality Systems Specialist II. At Riverpoint you will be part of the process that brings innovative technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. Our ingenuity can be found in our suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies. The Quality Systems Specialist II will play a key role in maintaining and improving the Quality Management System (QMS) by ensuring compliance with regulatory requirements and internal policies. This role will oversee training system effectiveness, support audit preparation, manage Quality Management Review (QMR) activities, and contribute to CAPA processes and other critical quality functions. The candidate possesses a strong understanding of FDA CFR 820, ISO 13485, and MDR requirements.

Duties and 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.

Education and Qualifications

• Bachelor’s 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.

Benefits

• Medical, Dental and Vision
• Life and Accidental Death Insurance
• 401(k) with company match and immediate vesting
• Paid Time Off and 8 company paid holidays
• Bonus pay such as Referral Bonus and Annual Bonus

Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.