Position Code: 13-PD-110
Reports To: Quality Manager, Software
Department: Quality Assurance
The Software Senior Quality Engineer 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 Senior Quality Engineer 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, ISO and FDA QSR regulations.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
- Creating, updating, reviewing, and developing Software Life Cycle Management Program standard operating procedures and supporting work instructions based in ISO and FDA Quality System Regulations
- Supporting training of personnel in requirements of quality tools and techniques, QMS based on ISO /FDA 21 CFR 820 requirements
- Designing validation strategies and methodologies for the qualification and validation of software
- Preparing, managing, and executing qualification, verification/validation protocols (e.g. IQ/OQ/PQ) in accordance with cGMP requirements
- Supporting Change Control Board quality system/validation representation
- Supporting Product Life Cycle/Development (PLC/NPD) quality/regulatory inputs for design and phase reviews
- 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 Validation Engineer or equivalent with experience in a medical device or clinical laboratory environment
- Very experienced working with a variety of software development methodologies, such as Agile Sprint/Scrum and Continuous Integration
- Experience using various bug tracking and reporting software systems such as Bugzilla, Jira, Chili Pepper, etc
- Experience working with software engineers to identify and document software bugs and enhancements
- Adept at black-box and white-box testing
- Experience with computerized system validation is required
- 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 will be viewed favorably
- Experience in medical device / Biotech start-up/fast growth company or similar working environment will be viewed favorably
- Working knowledge of cGMP’s will be viewed favorably
- Knowledge of Clinical and HIPPA regulations as it applies to software will be viewed favorably
- Quality certification will be viewed favorably
Complete Genomics does not accept unsolicited agency resumes. Please do not forward unsolicited agency resumes to our website, employees or Human Resources.
Complete Genomics will not pay fees to any third party agency or firm and will not be responsible for any agency fees associated with unsolicited resumes. Unsolicited resumes received will be considered property of Complete Genomics and will be processed accordingly without fee.
Complete Genomics has the sole discretion to determine with whom we will enter into a contract. If you wish to work with Complete Genomics, please contact the Human Resources department at firstname.lastname@example.org .
Complete Genomics is proud to be an equal opportunity employer
Complete Genomics was formed in 2005 by Dr. Clifford A. Reid and Dr. Radoje T. Drmanac, who shared a vision to provide academic and...