Software Quality Engineer at kyyba
Burlington, MA
About the Job
Need someone with Software Quality experience working on test case review, software
verification and software risk assessment (SRA) or Software FMEA.
Need someone that has worked in the medical device industry and has experience in
medical device regulation as well as knowledge of IEC62304.
Position is onsite and can be located in either Burlington MA, Pleasanton CA, or Atlanta,
GA. Position location is in Burlington (preferred) or Atlanta and 100% onsite.
Looking for someone who can work cross functionally across teams within the
organization.
IEC 62304 exp required. Master's fresh out of school acceptable if they have knowledge
of regulated environment, biomedical project exp. Med device experience required.
Refer to FG template for more information.
This position is responsible for executing and maintaining quality engineering
methodologies and providing quality engineering support for software
Duties: Develop and conduct training of company personnel for the divisional software
development and validation program.
Work with Design and Manufacturing Engineering in the completion of system/software
requirements and other verification and validatiton processes.
Create and execute or direct software validation protocols traceable to system/software
requirements. Implement solutions for controlling code and administer Code Control and
Software Event/Defect Tracking software systems.
Assist in the completion and maintenance of risk analysis, focused on software related
risks. Design and implement various product and process improvement methodologies
(i.e, Six Sigma and Lean Manufacturing).
Apply sound, systematic problem solving methodologies in identifying, prioritizing,
communicating and resolving issues.
Software scoping and Part 11 audits. Support all Company initiatives as identified by
management and in support of Quality Management Systems (QMS), Environmental
Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory
requirements, Company policies, operating procedures, processes, and task
assignments. Maintains positive and cooperative communications and collaboration with
all levels of employees, customers, contractors, and vendors.
Performs other related duties and responsibilities, on occasion, as assigned.
Qualifications: BS Degree in Engineering or Technical Field or equivalent experience. 2-
5 years Software Quality Engineering experience.
Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485. Advanced computer
skills, including statistical/data analysis and report writing.
Advanced Information Technology and data mining skills. Prior medical device
experience preferred. A
SQ CSQE certification desired. Experience working in a broader enterprise/cross-
division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing
environment.
Ability to leverage and/or engage others to accomplish projects. Strong verbal and
written communications with ability to effectively communicate at multiple levels in the
organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong
organizational and follow-up skills, as well as attention to detail.
Ability to travel including internationally. Ability to maintain regular and predictable
attendance.
verification and software risk assessment (SRA) or Software FMEA.
Need someone that has worked in the medical device industry and has experience in
medical device regulation as well as knowledge of IEC62304.
Position is onsite and can be located in either Burlington MA, Pleasanton CA, or Atlanta,
GA. Position location is in Burlington (preferred) or Atlanta and 100% onsite.
Looking for someone who can work cross functionally across teams within the
organization.
IEC 62304 exp required. Master's fresh out of school acceptable if they have knowledge
of regulated environment, biomedical project exp. Med device experience required.
Refer to FG template for more information.
This position is responsible for executing and maintaining quality engineering
methodologies and providing quality engineering support for software
Duties: Develop and conduct training of company personnel for the divisional software
development and validation program.
Work with Design and Manufacturing Engineering in the completion of system/software
requirements and other verification and validatiton processes.
Create and execute or direct software validation protocols traceable to system/software
requirements. Implement solutions for controlling code and administer Code Control and
Software Event/Defect Tracking software systems.
Assist in the completion and maintenance of risk analysis, focused on software related
risks. Design and implement various product and process improvement methodologies
(i.e, Six Sigma and Lean Manufacturing).
Apply sound, systematic problem solving methodologies in identifying, prioritizing,
communicating and resolving issues.
Software scoping and Part 11 audits. Support all Company initiatives as identified by
management and in support of Quality Management Systems (QMS), Environmental
Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory
requirements, Company policies, operating procedures, processes, and task
assignments. Maintains positive and cooperative communications and collaboration with
all levels of employees, customers, contractors, and vendors.
Performs other related duties and responsibilities, on occasion, as assigned.
Qualifications: BS Degree in Engineering or Technical Field or equivalent experience. 2-
5 years Software Quality Engineering experience.
Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485. Advanced computer
skills, including statistical/data analysis and report writing.
Advanced Information Technology and data mining skills. Prior medical device
experience preferred. A
SQ CSQE certification desired. Experience working in a broader enterprise/cross-
division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing
environment.
Ability to leverage and/or engage others to accomplish projects. Strong verbal and
written communications with ability to effectively communicate at multiple levels in the
organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong
organizational and follow-up skills, as well as attention to detail.
Ability to travel including internationally. Ability to maintain regular and predictable
attendance.