Senior Quality Engineer
Reduce process variation and increase process rigor throughout operations using quality tools, techniques and statistics
Create, update, review and develop Quality Management System standard operating procedures and supporting work instructions based in CLIA, CAP, CLEP, ISO 13485:
2016 and FDA Quality System Regulations
Support training of personnel in requirements of quality tools and techniques, QMS based on CLIA, CAP, CLEP, ISO 13485:
2016/FDA 21 CFR 820 requirements
Perform root cause data analysis, using statistical techniques and maintain supporting databases for CAPA systems
Write and perform qualification, verification/validation protocols (e.g. IQ/OQ/PQ)
Create and maintain quality metrics as they relate to manufacturing processes and related activities for analysis and continual improvement
Support supplier qualification and evaluation
Support Material Review Board (MRB) activities
Support Change Control Board quality system/validation representation
Support Product Life Cycle/Development (PLC/NPD) quality/regulatory inputs for design and phase reviews
Any and all other undefined tasks, as directed by your supervisor
About you
B.S./B.A. in Engineering, Chemistry or Life Science. 5
years as a QE or equivalent with experience in medical device environment with knowledge of database management, CLIA, CAP, CLEP, ISO 13485:
2003/FDA QSR quality systems lead auditor training, CAPA system maintenance, and process development, verification/ validation
Critical to have a working knowledge of Quality Statistics, tools, SPC, Six Sigma and Lean techniques and methodologies
Ability to apply quality tools to develop new quality processes focused on process rigor and reduction in variation throughout operations
Experience in the development and maintenance of databases for tracking of quality system data and production defects
Active participation in root cause analysis and process improvement using quality methodologies, DMAIC, SPIOC, etc.
Basic understanding of Chemistry and Molecular Biology, as it pertains to DNA sequencing
Experience with developing and improving processes within a reagent manufacturing environment
Experience in medical device / Biotech start-up / fast growth company, or similar working environment
Working knowledge of cGMP's
ISO15189 Experience a plus
Advanced education a plus
ASQ CQE highly preferred
Counsyl is a health technology company that offers DNA screening for diseases that can impact men, women and their children. The Counsyl philosophy is simple:
screen for diseases where advanced knowledge makes a difference in health outcomes, whether it's changing a behavior, pursuing preventative measures, or simply preparing for what lies ahead.
The Counsyl team includes an accomplished group of problem-solvers top engineers, scientists, and designers who are taking the lead on building the modern clinical laboratory. Scientific rigor, custom robotics, and software are at the heart of every Counsyl product, resulting in better, faster and more affordable screens that are broadly accessible. Beyond the laboratory, Counsyl offers doctors and patients a technology platform for results delivery in real time, with on-demand access to board-certified genetic counselors.
Counsyl has screened more than 750,000 patients and served more than 10,000 health care professionals in its CLIA-certified, CAP-accredited and NYS CLEP-permitted clinical laboratory. The company has raised a total of $102 million and is privately backed by Pilot Growth Equity, Goldman Sachs Asset Management, Founders Fund, Felicis Ventures, David Drummond, and other high profile investors.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
Create, update, review and develop Quality Management System standard operating procedures and supporting work instructions based in CLIA, CAP, CLEP, ISO 13485:
2016 and FDA Quality System Regulations
Support training of personnel in requirements of quality tools and techniques, QMS based on CLIA, CAP, CLEP, ISO 13485:
2016/FDA 21 CFR 820 requirements
Perform root cause data analysis, using statistical techniques and maintain supporting databases for CAPA systems
Write and perform qualification, verification/validation protocols (e.g. IQ/OQ/PQ)
Create and maintain quality metrics as they relate to manufacturing processes and related activities for analysis and continual improvement
Support supplier qualification and evaluation
Support Material Review Board (MRB) activities
Support Change Control Board quality system/validation representation
Support Product Life Cycle/Development (PLC/NPD) quality/regulatory inputs for design and phase reviews
Any and all other undefined tasks, as directed by your supervisor
About you
B.S./B.A. in Engineering, Chemistry or Life Science. 5
years as a QE or equivalent with experience in medical device environment with knowledge of database management, CLIA, CAP, CLEP, ISO 13485:
2003/FDA QSR quality systems lead auditor training, CAPA system maintenance, and process development, verification/ validation
Critical to have a working knowledge of Quality Statistics, tools, SPC, Six Sigma and Lean techniques and methodologies
Ability to apply quality tools to develop new quality processes focused on process rigor and reduction in variation throughout operations
Experience in the development and maintenance of databases for tracking of quality system data and production defects
Active participation in root cause analysis and process improvement using quality methodologies, DMAIC, SPIOC, etc.
Basic understanding of Chemistry and Molecular Biology, as it pertains to DNA sequencing
Experience with developing and improving processes within a reagent manufacturing environment
Experience in medical device / Biotech start-up / fast growth company, or similar working environment
Working knowledge of cGMP's
ISO15189 Experience a plus
Advanced education a plus
ASQ CQE highly preferred
Counsyl is a health technology company that offers DNA screening for diseases that can impact men, women and their children. The Counsyl philosophy is simple:
screen for diseases where advanced knowledge makes a difference in health outcomes, whether it's changing a behavior, pursuing preventative measures, or simply preparing for what lies ahead.
The Counsyl team includes an accomplished group of problem-solvers top engineers, scientists, and designers who are taking the lead on building the modern clinical laboratory. Scientific rigor, custom robotics, and software are at the heart of every Counsyl product, resulting in better, faster and more affordable screens that are broadly accessible. Beyond the laboratory, Counsyl offers doctors and patients a technology platform for results delivery in real time, with on-demand access to board-certified genetic counselors.
Counsyl has screened more than 750,000 patients and served more than 10,000 health care professionals in its CLIA-certified, CAP-accredited and NYS CLEP-permitted clinical laboratory. The company has raised a total of $102 million and is privately backed by Pilot Growth Equity, Goldman Sachs Asset Management, Founders Fund, Felicis Ventures, David Drummond, and other high profile investors.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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