Quality Assurance Specialist, Sr

Magnolia Medical Technologies•Seattle, WA

7d•Onsite

About The Position

The Senior Quality Assurance Specialist , Quality Systems will be part of a small and nimble Quality and Regulatory group that is creating revolutionary devices to improve sample collection and integrity for critical in-vitro diagnostic (IVD) tests. The primary purpose of the Quality Assurance Specialist, Sr (QA Specialist, Sr) Quality Systems, is to be responsible for supporting quality system activities. This highly motivated member of the QA/RA team will maintain the quality management system (QMS), lead the Document and Change Control processes within the electronic Quality Management System (eQMS), while serving as the system owner. Additional responsibilities include supporting internal and external audits, deviation/NCMR/CAPA management, Complaint intake, and Lot release, all while promoting a culture of compliance throughout the organization through continuous improvement initiatives. This position will report to the department's acting Head of QA/RA and is located in our downtown Seattle office. The incumbent will work closely with the team's Quality Engineers as well as Engineering, Supply Chain and Manufacturing teams in the Operations Department and cross functionally across the organization to achieve the organization's quality standards and goals. About Us Magnolia Medical is an emerging growth commercial-stage medical device company that is developing solutions to challenges that have long plagued our healthcare system. Our Steripath® Initial Specimen Diversion Device® for blood collection and contamination prevention has created a new standard of care for prevention of false positive blood cultures, the gold standard diagnostic test for sepsis. Steripath delivers significant clinical and cost savings benefits which have been extensively proven with large bodies of clinical data and peer-reviewed published studies. Based on this exceptional performance profile, we have an exclusive FDA-cleared blood diversion device for reducing blood culture contamination and uniquely provide a money-back Clinical Performance Guarantee for Steripath to our hospital customers. With strong institutional investor backing, we offer highly committed and qualified candidates the opportunity to be a part of building a company dedicated to dramatically improving the accuracy of sepsis diagnostics to positively impact patient outcomes and hospital economics.

Requirements

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.
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.

Nice To Haves

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

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.