Magnolia Medical Technologies · 1 month ago
Quality Assurance Specialist, Sr
Seattle, Washington, United States
Full-time
Onsite
Mid, Senior Level
$92K/yr - $112K/yr
3+ years expMagnolia Medical Technologies is an emerging growth commercial-stage medical device company focused on improving healthcare solutions. The Senior Quality Assurance Specialist will support quality system activities, maintain the quality management system, and lead various processes while promoting a culture of compliance throughout the organization.
Health CareHealth DiagnosticsMedical Device
Responsibilities
Work with Head of QA/RA to define, implement, and improve the Quality Management System (QMS)
Write, review and revise Standard Operating Procedures (SOPs)
Review and control documents in accordance with document control procedures
Oversee document templates and change control processes
Managing QMS events such as deviations, NCMR, CAPAs, change controls, and complaints, related to systems
Owns system administrative activities for the QMS
Addresses any user-related issues and provides end user support in the QMS
Assists in user setup of the quality management system
Partner with functional leaders to define system training plans and ensure timely completion of all training assignments
Support internal and external audits and regulatory inspections
Other duties as assigned
Qualification
Required
Bachelor's degree or equivalent
3+ years experience in Quality Systems in regulated environment
Familiarity with 21 CFR 820, ISO 13485, ISO 14971, and domestic Medical Device regulatory requirements
Experience with ensuring alignment with relevant cGMP, GDocP, and QMS guidance and regulations
Thorough knowledge of records management, scanning, and organizing functions
Involvement in continuous improvement initiatives
Proficient use of MS Office products, as well as ownership of GMP electronic applications (e.g., Salesforce platform)
Ability to meet deadlines, adapt to rapid changes, and work in a fast-paced team environment
Ability to work effectively both independently and with other team members
A strong sense of ownership, great communication skills, and excellent time management skills
Interpersonal skills including the ability to influence without authority and negotiate and resolve challenges with poise, tact, and diplomacy
Must be able to lift 20lbs occasionally and perform computer work requiring typing and vision
Preferred
Library Science a plus
Familiarity with Contract Manufacturing Organizations (CMO) and ERP systems, desirable
Company
Magnolia Medical Technologies
Magnolia Medical Technologies is a device development company that focuses on improving the accuracy of diagnostic blood culture tests. It is a sub-organization of Medtronic.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$117.33MKey Investors
Horizon Technology FinanceRTW InvestmentsEvidity Health Capital
2022-02-16Private Equity· $46M
2020-05-27Debt Financing· $20M
2019-01-30Series C· $20M
Leadership Team
R. Jason Richey
President & Chief Executive Officer
J
Joseph Bishop
Chief Operating Officer
Recent News
2026-01-09
Medical Product Outsourcing
2025-08-01
2025-07-31
Company data provided by crunchbase