LanceSoft Inc
Lead Software Quality Engineer
Location:
Pleasanton, CA 94588
Duration:
12 Months
Description:
This position is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering and risk assessment support for software utilized throughout the division.
Duties
Work with Design and Test Engineering in the completion of system/software requirements and other verification and validation processes.
Review software validation protocols traceable to system/software requirements.
Participate in meetings and provide guidance on Software Event/Defect or anomalies.
Responsible for driving the completion and maintenance of risk analysis, focused on software related risks.
Design and implement various product and process improvement methodologies (ie 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.
At least 5 years Quality Engineering experience.
Detailed knowledge of FDA QSR, IEC 62304, and ISO 13485.
Advanced computer skills, including data analysis and report writing skills.
Prior medical device or IVD experience preferred.
ASQ 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 maintain regular and predictable attendance.
Looking for someone well versed in software verification and validation and risk controls/activities and trace matrix.
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Pleasanton, CA 94588
Duration:
12 Months
Description:
This position is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering and risk assessment support for software utilized throughout the division.
Duties
Work with Design and Test Engineering in the completion of system/software requirements and other verification and validation processes.
Review software validation protocols traceable to system/software requirements.
Participate in meetings and provide guidance on Software Event/Defect or anomalies.
Responsible for driving the completion and maintenance of risk analysis, focused on software related risks.
Design and implement various product and process improvement methodologies (ie 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.
At least 5 years Quality Engineering experience.
Detailed knowledge of FDA QSR, IEC 62304, and ISO 13485.
Advanced computer skills, including data analysis and report writing skills.
Prior medical device or IVD experience preferred.
ASQ 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 maintain regular and predictable attendance.
Looking for someone well versed in software verification and validation and risk controls/activities and trace matrix.
#J-18808-Ljbffr