T2 Biosystems, founded in 2006 by renowned scientists from MIT and Mass General Hospital, is an in vitro diagnostic company that has developed an innovative and proprietary technology platform that offers a rapid, sensitive and simple alternative to existing diagnostic methodologies. We are using our T2 Magnetic Resonance platform, or T2MR, to develop a broad set of applications aimed at reducing mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables rapid detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, and can detect cellular targets as limits of detection as low as one colony forming unit per milliliter, or CFU/ml. Our initial development efforts utilizing T2MR target sepsis and hemostasis, which are areas of significant unmet medical need in which existing therapies could be more effective with improved diagnostics. We have completed a pivotal clinical trial for our T2Dx diagnostic instrument, or T2Dx, and T2 Candida panel, or T2Candida, which have the ability to rapidly identify the five clinically relevant species of Candida, a fungal pathogen known to cause sepsis.
On September 22, 2014, T2 Biosystems received market authorization from the U.S. Food and Drug Administration (FDA) for its first two products, the T2Candida® Panel and the T2Dx® Instrument for the direct detection of Candida species in human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections. T2Candida and T2Dx, for the first time, provide sensitive detection of specific sepsis-causing pathogens directly from a whole blood specimen in approximately four hours. All other currently FDA-cleared detection systems require cultured blood samples for species-specific identification and take two to five days or more to provide results.
T2 Biosystems was named to the FierceMedicalDevices "Fierce 15" list in 2012, received the prestigious SBANE award in 2013 and received the Most Promising Company award at the Personalized Medicine World Conference in 2014.
We are seeking a talented and highly motivated individual to join our team as a Senior Quality Assurance Analyst .
Summary:
- Responsible for supporting the quality assurance department promoting product quality and quality system compliance consistent with T2 Biosystems’ company goals including the direction, planning and execution of quality improvement initiatives.
- Supports the establishment and maintenance of the Quality System in compliance with QSR, EN ISO, and IVDD regulations. Manages multiple programs, and interfaces with a variety of internal and external stakeholders.
Duties &Responsibilities:
- Technical writing to support required Quality Management System documentation.
- Conduct internal audits and support timely completion of audit findings.
- Work with teams to define and develop action plans and support timely closure of Corrective and Preventative Actions (CAPA).
- Generate quality reports that track cycle times, yields/quality rates, and evaluate trends through Pareto charts for various quality system and product performance metrics.
- Perform supplier assessments and improve supplier monitoring through improved trending, scorecards, and reports.
- With the R&D team define a comprehensive risk management plan for development activities in accordance with ISO 14971.
- Develop IQ, OQ and PQ protocols for measurement, test, quality system and manufacturing equipment/software; execute protocols and generate reports as necessary.
- Troubleshoot process problems, define root causes, coordinate implementation of corrective actions and verify corrective action effectiveness.
- Utilize quality principles and problem solving skills (risk analysis, statistical techniques, etc.) to address product design and manufacturing issues.
- Support process and product-related deviation activities including tracking and trending.
- Disposition, process, and track non-conforming material reports (NCMRs).
- Support complaint investigation, record keeping and trend reporting.
- Review Quality System records for conformance to specified requirements.
Required Experience:
- BS in related Life Sciences
- ASQ or six Sigma certification or equivalent is desired
- 8+ years in the medical device industry serving in Quality Assurance function. Experience with In Vitro Diagnostic products preferred.
- Extensive experience in Quality Systems compliant with EN ISO 13485, ISO 14971, IVDD, and 21CFR Part 820.
- Technical writing with strong work processing proficiency
- Statistical sampling and data analysis, strong proficiency with Microsoft Excel.
- Ability to define problems, collect data, establish facts, and draw valid statistical conclusions.
- Knowledge of inspection techniques and equipment
Additional Attributes:
- A team player adept at working collaboratively in an R&D environment.
- Excellent organizational skills,
- A strong work ethic to generate high quality work under tight deadlines,
- A proactive attitude,
- Excellent communications skills (oral and written); proven ability to deal effectively with clinical practice thought leaders; effective communications to superior, peer and subordinate levels.
- Strong organizational and interpersonal skills.
- Demonstrable project management and creative problem solving skills.
- Preferred experience design controls, assay, and device manufacturing.
To apply, please follow the link to our careers page at: http://www.t2biosystems.com/careers/
T2 Biosystems is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, gender, pregnancy, national origin, age, military service eligibility, veteran status, sexual orientation, marital status, disability, or any other protected class.