- Coordinates with QA, Manufacturing, and other stakeholders on the timely review of records by tracking deliverables, monitoring timelines, and assisting individual contributors.
- Initiates, reviews, and approves complaints, NCRs, CAPAs, deviations and change orders.
- Supports post-market surveillance by coordinating the collection of post market surveillance information, maintaining databases, and authoring documentation required for post market reporting, coordination of FMEA review, and documenting periodic safety update reports.
- Supports implementation of process improvements to support field action readiness activities by coordinating internal documentation and data reviews, tracking corrective actions, and coordinating communication to regulatory authorities
- Applies risk assessment principles according to ISO 14971 requirements to make decisions related to T2 Biosystems' processes and products.
- Authors, monitors, approves, and ensures effectiveness of actions taken to resolve quality observations associated with complaints, corrective and preventative actions, changes, and/or other quality objectives or improvements.
- Works closely with Regulatory Affairs, Service and Quality Assurance Compliance by completing assigned tasks in accordance with procedures and within the designated timelines.
- Provides support for document management and training system administration.
- Supports driving continual improvements to T2 Biosystems' QMS.
- Supports audit preparation activities and actively participates in both front-room and back-room audit discussions, as appropriate.
- Effectively tracks project and quality plan deliverables (such as CAPA, Management Review actions, Quality Objectives, etc.)
- Works with internal customers to resolve quality issues in a timely manner.
- BS or BA Biology, Chemistry, Applied Biomedical Science degree or equivalent experience.
- Solid understanding of FDA QSR, ISO 13485, ISO 14971, and IVDR.
- 5-7 years of QA experience in the in-vitro diagnostic or medical device field preferred.
- Experience with customer complaints, medical device reporting, and post market surveillance activities.
- Demonstrate ability to apply Root Cause Analysis tools and structured problem-solving methodologies to QMS nonconformities.
- Quality auditing experience - exposure to internal and external audits.
- Comfortable working in a fast-paced work environment.
- Excellent time-management, organizational and communication skills. Ability to work with multiple groups within the organization.
- Ability to work independently, follow instructions accurately, and ask questions if instructions are unclear or circumstances are not as expected.
- Must enjoy multi-tasking and have a positive attitude.
- Communication with various functional departments will be critical to achieving successful outcomes.
- Working knowledge of GMP is required.
- Multitasking and ability to manage multiple projects simultaneously while maintaining critical timelines is required.
- High proficiency required with MS Office applications, particularly Excel, Word, Visio, and Outlook. Proficiency in Smartsheet, Salesforce, and Arena is preferred.
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Senior Quality Assurance Specialist - Lexington, United States - T2 Biosystems
Description
Senior Quality Assurance SpecialistDepartment: Quality Assurance
Employment Type: Full Time
Location: Lexington, MA
Reporting To: David Tessein
Description
We are seeking a collaborative and detail-oriented individual to join our team as a Sr. Quality Assurance Specialist. The position reports directly to the Manager, Quality Assurance.
The ideal candidate will be someone that enjoys working as part of a fast paced, cross-functional team, balancing multiple tasks, and focused on achieving results. They will lead by example with a positive attitude and will apply their critical thinking skills when getting things done. This individual must be able to communicate effectively with team members at all levels.
In addition to those skills and attributes, we're looking for someone that thrives in a rapidly growing environment and is interested in developing and advancing their career along with the organization.
Responsibilities
