Quality Systems Specialist II: Drive QMS & Compliance

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

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.