Job Description:
The Software Quality Manager is an enthusiastic, self-motivated person with great communication skills who can support the Quality Assurance program through building the software life cycle management program infrastructure as well as direct execution of software qualification and validation activities. The Software Quality Manager will demonstrate a high level of individual responsibility and accountability and possess the ability to perform to the requirements listed below. The candidate will be comfortable in a rapidly evolving Biotech start-up environment assisting in the implementation of a value added QMS based on CLIA, CAP, CLEP, ISO 13485:2003 and FDA QSR regulations. What you'll do:
Additional Info:
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.[Click Here to Access the Original Job Post]
The Software Quality Manager is an enthusiastic, self-motivated person with great communication skills who can support the Quality Assurance program through building the software life cycle management program infrastructure as well as direct execution of software qualification and validation activities. The Software Quality Manager will demonstrate a high level of individual responsibility and accountability and possess the ability to perform to the requirements listed below. The candidate will be comfortable in a rapidly evolving Biotech start-up environment assisting in the implementation of a value added QMS based on CLIA, CAP, CLEP, ISO 13485:2003 and FDA QSR regulations. What you'll do:
- Creating, updating, reviewing, and developing Software Life Cycle Management Program standard operating procedures and supporting work instructions based in CLIA, CAP, CLEP, ISO 13485:2016 and FDA Quality System Regulations
- Supporting training of personnel in requirements of quality tools and techniques, QMS based on ISO 13485:2016/FDA 21 CFR 820 requirements
- Designing validation strategies and methodologies for the qualification and validation of software.
- Preparing, managing, and executing qualification, SW verification/validation protocols (e.g. IQ/OQ/PQ) in accordance with cGMP requirements
- Implementation and support of technology transfer program (Change Control)
- Supporting Change Control Board quality system/validation representation
- Supporting Product Life Cycle/Development (PLC/NPD) quality/regulatory inputs for design and phase reviews
- Training SW developers in design control and regulated software industry practices
- Working around Production Department schedules to gain access to equipment/systems required for execution of validation protocols. May require performing critical validations on aggressive timetables.
- Any and all other undefined tasks, as directed by your supervisor
- Minimum, B.S./B.A. in Computer Science, Engineering, Chemistry or Life Science. 5+ years as a Software Quality Manager or equivalent with experience in a medical device or clinical laboratory environment.
- Experience with computerized system validation is required.
- Working knowledge of regulated software standards and application: ISO62304, GAMP 5 and risk management ISO14971
- Demonstrated knowledge of Risk Assessment tools, Quality Statistics, Reliability Engineering, Six Sigma and Lean techniques and methodologies
- Experience in the development and maintenance of databases for tracking of quality system data and production defects
- Basic understanding of Bioinformatics as it pertains to DNA sequencing and genomics
- Experience in medical device / Biotech start-up/fast growth company or similar working environment
- Working knowledge of cGMP’s
- Advanced education a plus
- ASQ CQM, CQE, CRE, or CSQE highly preferred
Requeriments :
Skills :
Additional Info:
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.[Click Here to Access the Original Job Post]