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Software Quality Analyst (SQA)

Sky System Inc

Remote, OR(remote)

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JOB DETAILS
JOB TYPE
Full-time
SKILLS
Analysis Skills, Cataloguing, Change Management, Code Reviews, Control Systems, Cross-Functional, Document Control, Document Management, Documentation, FDA (Food and Drug Administration), Information Systems/Technology IS/IT Administration, Internal Audit, Maintain Compliance, Manufacturing, Medical Equipment, Mentoring, Performance Analysis, Performance Metrics, Quality Management, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Regulatory Requirements, Software Testing, Technical Support, Training Program, Vendor/Supplier Management, Work From Home
LOCATION
Remote, OR
POSTED
30+ days ago
100% Remote Work Hours: 9am-5pm US time (EST) Contract Duration: 6-12 months (renewable) Role: Ensures site activities associated with medical device manufacturing and testing comply with quality management systems and applicable regulatory requirements. Coordinates Quality Management Systems ensuring compliance to all relevant regulations and standards including FDA QSR Part 820; including change management, record retention, training, and assist with the internal audit program. Essential Function: Organizes documents for management review, software release, and audits Creates and monitors reports for departmental key performance indicators, tracks and trends Administers the document control system including monitoring, cataloging and reporting on the status and stages of various documents Manages the medical device complaint process including documentation and fielding of issues to the appropriate parties for investigation and resolution Coordinates quality and regulatory compliance training programs for the department Promotes culture of quality and mentors cross-functional teams Provides support to the supplier management process Provides administrative support to all Information Technology departments as required. Required Skills: Associate's degree from an accredited college or university and two (2) years of experience in a laboratory or blood bank environment as well as prior customer relations experience or an equivalent combination of education, training and/or experience.

About the Company

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Sky System Inc