Overview
Director of Quality Assurance Jobs in Portland, Oregon Metropolitan Area at Arevna
Title: Director of Quality Assurance
Company: Arevna
Location: Portland, Oregon Metropolitan Area
Quality Director – Medical Devices | On-Site | Portland, OR
A leading medical device company is seeking an experienced Quality Director to lead and manage its Quality Management System (QMS) at its corporate headquarters in Portland, Oregon. This is an opportunity to drive quality assurance, compliance, and continuous improvement initiatives for a company specializing in advanced medical technologies.
About the Role
As the Quality Director, you will ensure that all products meet regulatory, safety, and performance standards while overseeing compliance with ISO 13485, FDA regulations, and other international standards. You will work cross-functionally with engineering, production, and regulatory teams to uphold quality control throughout product development and manufacturing. This role requires a strong leader who can implement risk management strategies, lead audits, drive corrective actions, and foster a culture of quality and compliance.
Key Responsibilities
Oversee the implementation and maintenance of the Quality Management System (QMS), ensuring compliance with internal policies and regulatory requirements.
Lead internal audits, CAPAs, complaints, change control, document control, incoming inspections, and manufacturing oversight.
Drive continuous improvement initiatives to optimize quality procedures and enhance compliance efforts.
Ensure all processes and products meet regulatory and internal quality standards while maintaining cost efficiency.
Lead, mentor, and develop the quality assurance team, fostering a culture of quality across the organization.
Define, implement, and improve policies and procedures related to the QMS.
Lead cross-functional projects to drive operational excellence and implement sustainable quality improvements.
Identify risks and potential issues, implementing preventive actions to mitigate quality concerns.
Manage and lead FDA, international regulatory, and customer audits.
Develop and oversee departmental strategies, aligning with overall business objectives.
Collaborate with R&D, engineering, and manufacturing teams to ensure product quality from design to final production release.
Prepare and analyze quality performance KPIs, identifying trends and opportunities for improvement.
Qualifications
5+ years of leadership experience in quality assurance within an FDA-regulated environment.
Bachelor’s degree in engineering, life sciences, or related field, or equivalent work experience.
Strong knowledge of GMP, QSR, ISO 13485, MDSAP, MDR, and global regulatory requirements.
Proven track record of quality system management, audits, and regulatory compliance.
Experience with project management, process improvement, and team leadership.
Proficiency in MS Office, ERP systems, and statistical software (e.g., Minitab) preferred.
Strong written and verbal communication skills with the ability to engage cross-functional teams.
What’s in it for you?
Competitive salary and comprehensive benefits package.
Medical, dental, vision, 401(k) with company match, and more.
Opportunity to lead quality initiatives for cutting-edge medical technology.
On-site position in Portland, OR.
If you’re ready to take on a leadership role in quality assurance, apply today.
