Quality Systems Specialist II at RIVERPOINT MEDICAL LLC

Portland, Oregon, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Apr, 26

Salary

0.0

Posted On

06 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management System, FDA CFR 820, ISO 13485, MDR Requirements, Training Program, Audit Preparation, CAPA Processes, Continuous Improvement, Regulatory Compliance, Documentation, Quality Metrics, Cross-Functional Collaboration, Corrective Actions, Quality Assurance, Change Management, Nonconformances

Industry

Medical Equipment Manufacturing

Description

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: • 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 • Previous QC experience preferred We offer great 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. We also reward our team with 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.

Responsibilities

The Quality Systems Specialist II will maintain and improve the Quality Management System by ensuring compliance with regulatory requirements and internal policies. This role includes overseeing training system effectiveness, supporting audit preparation, and managing Quality Management Review activities.