Senior Quality Assurance Analyst
Company Name:
Talent Acquisition
We are seeking a talented and highly motivated individual to join our team as a Senior Quality Assurance Analyst. This position will report directly to the Senior Director of Quality Assurance.
Summary:
This role will participate in product development to promote product quality and quality system compliance.
Responsibilities:
Utilize quality principles and problem solving skills (risk analysis, statistical techniques, etc.) to develop and optimize product design and manufacturing through design control process.
In-depth knowledge of managing CAPA's and Deviations in a quality management system.
Coordinate and/or directly review and approve design history file (DHF), device master record (DMR) and device history record (DHR) documentation.
Working with R&D, develop, review and approve verification and validation protocols, work instructions, forms and reports as necessary.
Troubleshoot process problems, define root causes, coordinate implementation of corrective actions and verify corrective action effectiveness.
Develop IQ, OQ and PQ protocols for measurement, test, quality system and manufacturing equipment/software; execute protocols and generate reports as necessary.
Define quality system requirements for suppliers and perform supplier audits to establish objective evidence of supplier capabilities.
Manage process and product-related deviation activities to mitigate risk to our quality management system.
With the R&D team, define a comprehensive risk management plan for development activities in accordance with ISO 14971.
Skills and
Experience:
BS in Chemistry, Biology, or Life sciences, or equivalent education is required.
A minimum of five years' Quality Assurance experience within an FDA regulated environment required.
ASQ or Six Sigma certification or equivalent is desired.
Proven experience in Quality Systems with an emphasis on ISO 13485, ISO 14971, IVDD and 21CFR Part 820.
Strong technical writing, statistical sampling and data analysis skills.
Knowledge of inspection techniques and equipment.
Ability to define problems, collect data, establish facts, and draw valid statistical conclusions.
Ability to read and interpret specifications and apply appropriate methods to inspect materials associated with these documents.
A team player adept at working collaboratively in an R&D environment.
Excellent organizational and interpersonal skills, strong work ethic and commitment to generate high quality work under tight deadlines.
A proactive and positive attitude.
Excellent communications skills (verbal and written); proven ability to deal effectively with clinical practice thought leaders.
Demonstrable project management and creative problem solving skills.
Preferred experience in both assay and instrument manufacturing.
Interested? Visit our Careers page at www.t2biosystems.com and apply online. We look forward to hearing from you! Or Say hello to us and send a cover letter, along with your resume.
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 at 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. Upon receiving regulatory clearance, we intend to commercialize T2Dx and T2 Candida and our goal is to launch these product candidates commercially in the United States in the first half of 2015.
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.
Estimated Salary: $20 to $28 per hour based on qualifications.
Talent Acquisition
We are seeking a talented and highly motivated individual to join our team as a Senior Quality Assurance Analyst. This position will report directly to the Senior Director of Quality Assurance.
Summary:
This role will participate in product development to promote product quality and quality system compliance.
Responsibilities:
Utilize quality principles and problem solving skills (risk analysis, statistical techniques, etc.) to develop and optimize product design and manufacturing through design control process.
In-depth knowledge of managing CAPA's and Deviations in a quality management system.
Coordinate and/or directly review and approve design history file (DHF), device master record (DMR) and device history record (DHR) documentation.
Working with R&D, develop, review and approve verification and validation protocols, work instructions, forms and reports as necessary.
Troubleshoot process problems, define root causes, coordinate implementation of corrective actions and verify corrective action effectiveness.
Develop IQ, OQ and PQ protocols for measurement, test, quality system and manufacturing equipment/software; execute protocols and generate reports as necessary.
Define quality system requirements for suppliers and perform supplier audits to establish objective evidence of supplier capabilities.
Manage process and product-related deviation activities to mitigate risk to our quality management system.
With the R&D team, define a comprehensive risk management plan for development activities in accordance with ISO 14971.
Skills and
Experience:
BS in Chemistry, Biology, or Life sciences, or equivalent education is required.
A minimum of five years' Quality Assurance experience within an FDA regulated environment required.
ASQ or Six Sigma certification or equivalent is desired.
Proven experience in Quality Systems with an emphasis on ISO 13485, ISO 14971, IVDD and 21CFR Part 820.
Strong technical writing, statistical sampling and data analysis skills.
Knowledge of inspection techniques and equipment.
Ability to define problems, collect data, establish facts, and draw valid statistical conclusions.
Ability to read and interpret specifications and apply appropriate methods to inspect materials associated with these documents.
A team player adept at working collaboratively in an R&D environment.
Excellent organizational and interpersonal skills, strong work ethic and commitment to generate high quality work under tight deadlines.
A proactive and positive attitude.
Excellent communications skills (verbal and written); proven ability to deal effectively with clinical practice thought leaders.
Demonstrable project management and creative problem solving skills.
Preferred experience in both assay and instrument manufacturing.
Interested? Visit our Careers page at www.t2biosystems.com and apply online. We look forward to hearing from you! Or Say hello to us and send a cover letter, along with your resume.
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 at 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. Upon receiving regulatory clearance, we intend to commercialize T2Dx and T2 Candida and our goal is to launch these product candidates commercially in the United States in the first half of 2015.
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.
Estimated Salary: $20 to $28 per hour based on qualifications.
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