Quality Manager, R&D & Operations QA/RA

Quality Manager, R&D & Operations QA/RA

The Quality Manager, R&D & Operations QA/RA a critical leadership role within a scaling, high-growth organization developing innovative medical devices to improve sample collection and integrity for in-vitro diagnostic (IVD) testing. This role combines hands-on quality system ownership with people leadership, including coaching, mentoring, and development of direct reports.

Based onsite at the downtown Seattle corporate headquarters, this position partners closely with executive leadership and cross-functional teams to scale a robust, compliant Quality Management System (QMS) aligned with ISO 13485, MDSAP, and EU MDR.

POSITION DESCRIPTION

The Quality Manager, R&D & Operations QA/RA is responsible for the effectiveness, compliance, and continuous improvement of the organization’s QMS while leading a Quality team. The role serves as the Quality and Regulatory subject matter expert, management representative and eQMS owner, ensuring regulatory readiness as the company scales products, operations, and partnerships.

This leader will guide all aspects of the Quality and Regulatory system while fostering a culture of quality, accountability, and continuous improvement throughout the organization.

KEY RESPONSIBILITIES

• Lead, coach, and mentor Quality team members, providing clear expectations, performance feedback, and development opportunities
• Define, implement, scale, and continuously improve the QMS in compliance with ISO 13485, FDA QSR (21 CFR 820), and applicable IVD regulations
• Serve as Quality Systems SME and primary point of contact for ISO 13485, MDSAP, and EU MDR
• Author, review, approve, and maintain SOPs, work instructions, and quality records
• Oversee document control, document templates, and change control processes
• Manage and trend QMS events including deviations, nonconformances, CAPAs, complaints, and system-related design controls
• Ensure effective root cause analysis and timely closure of quality events
• Develop and execute quality system training strategies in partnership with functional leaders
• Ensure timely training completion and documentation in compliance with FDA and ISO requirements
• Support and lead internal audits, supplier audits, and external audits including ISO 13485 certification audits and FDA inspections
• Drive audit readiness activities, inspection response coordination, and remediation efforts
• Support supplier quality activities and oversight of Contract Manufacturing Organizations (CMOs)
• Champion continuous improvement initiatives to enhance QMS efficiency and scalability
• Maintain regular on-site attendance during business hours
• Perform other duties as assigned

PHYSICAL AND WORK REQUIREMENTS

• Ability to sit and/or stand and work at a computer for extended periods
• Ability to use a keyboard, mouse, and standard office equipment
• Ability to lift up to 10–20 lbs occasionally
• Ability to communicate clearly and professionally in person and by phone

• Ability to Travel to Contract Manufacturing and Supplier sites as needed (est 15-20%)

EXPERIENCE AND QUALIFICATIONS

• Bachelor’s degree (BA/BS) in science, engineering, or related discipline, or equivalent combination of education and experience
• 6–9 years of progressive experience in Quality Systems within a regulated medical device or IVD environment
• Demonstrated experience scaling Quality Systems within a growing or transitioning organization
• Proven experience leading, coaching, and mentoring direct reports
• Strong hands-on experience maintaining ISO 13485–certified Quality Management Systems
• Strong working knowledge of FDA Quality System Regulation (21 CFR Part 820) with experience supporting FDA inspections
• Familiarity with ISO 14971 (risk management), EU MDR, and global regulatory requirements
• Experience ensuring alignment with applicable cGMP, GDocP, and QMS regulatory guidance
• Experience managing deviations, CAPAs, change controls, complaints, and audit findings
• Experience supporting CMOs and supplier quality oversight
• Proficiency with Microsoft Office and GMP-compliant electronic systems (e.g., eQMS platforms, Salesforce or similar)
• Ability to prioritize, meet deadlines, and adapt in a fast-paced, scaling environment
• Strong written and verbal communication skills
• Demonstrated leadership, accountability, and decision-making skills
• Ability to influence without authority and effectively resolve challenges with professionalism and diplomacy

PREFERRED CERTIFICATIONS

• ASQ Certified Quality Auditor (CQA)
• Regulatory Affairs Certification (RAC)

About Magnolia Medical

Magnolia Medical Technologies, Inc. is redefining the accuracy of sepsis testing with Steripath®, the only device proven to reduce blood culture contamination significantly. With over 20 clinical studies, peer-reviewed publications, and an expanding IP portfolio, Magnolia Medical is establishing the new standard for blood culture integrity. The company offers competitive compensation, benefits, and incentive opportunities in a fast-growing, mission-driven environment.