What are the responsibilities and job description for the Quality Associate position at Elutia?
Position Overview :
The Quality Associate assists the Quality team in support of all Quality System related activities. This includes Supplier Management, Gap Analyses, Periodic Reviews, Quality Plan actions, Internal / External Audit activities, NMR, SCAR, CAPA, and coordinator activities for Document Control and Training. This position reports to the Senior Director, Quality.
Essential Responsibilities & Duties :
Maintain Supplier Management Files and the Approved Supplier List. Initiate Supplier Evaluations and obtain supporting evidence such as contracts, ISO / Quality certifications, supplier surveys, and audit reports.
Interpret regulations, complete gap analyses and determine any action items required for Elutia compliance. This may include completing actions and / or coordinating actions with other area management.
Assist with the completion of Periodic Reviews and Quality Plan action items and supporting documentation.
Assist Quality Management with the Internal Audit Program and External Audits. This may include acting as an Assistant Internal Auditor when assigned audit duties, assisting with audit scheduling, and coordinating follow-up corrective and preventive actions and supporting documentation.
Assist with the NMR, SCAR and CAPA Programs, as required. This may include completing corrective and preventive actions under the direction of Quality Management and / or coordinating actions with other area management.
Perform the day-to-day system coordinator activities associated with Document Control and Training within Grand Avenue.
Assist Quality Management with the qualification and on-going support of Grand Avenue Software modules and verification / validation of software generated LHRs. Run test scripts for software verification / validation as needed.
Organize and maintain Quality System Records in the Document Control Room and in off-site archives. Assist in maintaining of all Quality System Logs and Training Profiles.
Responsible for the identification of issues and initiation of actions to prevent the occurrence of any nonconformity relating to products, processes, or the quality system.
Education & Experience :
BA or BS degree or equivalent experience required. A degree in Quality, Life Science, a Physical Science, or Engineering is preferred.
3-5 years of work experience in a regulated environment (e.g, Medical Device, Pharmaceutical, or Life Sciences / Medical Industry). Previous Quality Systems experience is a plus.
Experience in the use of electronic document management systems is desired.
Good working knowledge of medical device manufacturing requirements and FDA QSR (21 CFR 820) and ISO 13485 requirements.
Advanced computer Skills in MS Office applications (Word, Excel, PowerPoint, Visio).
- Strategic-minded, analytical and detail-oriented.
Ability to handle multiple tasks and prioritize work appropriately with a focus on detail, timelines and deliverables.
Ability to work independently or as part of a team when required.
Certification Requirements :