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Magnolia Medical Technologies · 1 week ago

Quality Assurance Specialist, Sr

Seattle, WA

Full-time

Onsite

Mid, Senior Level

3+ years exp

Magnolia Medical Technologies is an emerging growth commercial-stage medical device company developing innovative solutions for healthcare challenges. The Senior Quality Assurance Specialist will support quality system activities, maintain the quality management system, and lead document and change control processes while promoting compliance and continuous improvement initiatives throughout the organization.

Health CareHealth DiagnosticsMedical Device

Growth Opportunities

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

Quality Management SystemDocument ControlRegulatory Compliance21 CFR 820ISO 13485ISO 14971CGMPGDocPRecords ManagementContinuous ImprovementMS OfficeSalesforceInterpersonal SkillsTime Management

Required

Bachelor's degree or equivalent. Library Science a plus. High School diploma/associate's degree with equivalent combination of education and work experience may be considered

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

Familiarity with Contract Manufacturing Organizations (CMO) and ERP systems, desirable

Benefits

Must be willing to submit to a criminal background check upon offer of employment.

Upon employment with Magnolia Medical Technologies, you are requested to provide proof that you are fully vaccinated against COVID-19.

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.

Founded in 2011

Seattle, Washington, USA

51-200 employees