Global provider of imaging and healthcare IT solutions, enhancing patient care and workflow efficiency.
Represents customer perspective in project quality decisions.
Documents and delivers to the appropriate repository all test results, analysis, and test summary reports
Provides clear scope definition, implements new tools, drives change management, and defines metrics that define successful completion.
Leads verification activities related to design change activities including testing assignments on updates to existing products.
Contributes to new product development/manufacturing in areas of design verification & validation of product requirements, regulatory requirements, specification development, measurable outcomes, hazard and safety analyses and other quality activities necessary to meet project objectives in the hardware/software/manufacturing arenas.
Leads product design teams through system Failure Mode Effects Analysis (FMEA) activities
Within the NDT Research and Development team, the Senior Quality Assurance Engineer is responsible for system test design, planning, and oversight of test execution on a variety of system products which are comprised of electronic and electro- mechanical components with embedded software control. The systems typically leverage common components including host application software (running on a windows PC) that provides the primary user interface with high level system coordination. The systems are sold to customers working in support of the Non-Destructive Testing industry.
Responsible for supporting design verification of new product design, development, and transfer of the resultant design to manufacturing along with process compliance to regulatory requirements.
Duties may include leading cross-functional corrective action team(s) or projects
Supporting Regulatory agency audits and inspections.
Duties may include activities to support the customer complaint process
Duties may include supplier quality and audit activities.
Develops schedules/resource plans for the verification and validation portion of a product design project
Creates and executes test plans
Excellent written and verbal communication
Ability to influence within peer group and higher management
Competent in the use of statistical software (ex. Minitab, Reliasoft, etc)
Excellent attention to detail
Traditional Office Environment: This position is primarily an office setting with standard temperature and humidity controls, moderate to light noise, fluorescent lighting, primarily sitting with standing desks available, extensive computer and keyboard use, etc.
Strong analytical, decision-making and problem-solving skills.
Quality Engineering, manufacturing or service experience within an ISO and/or FDA regulated medical device industry.
Bachelor's degree in Engineering (electrical or mechanical) or any STEM program.
Knowledge of industry standards such as AWS, ASME, API (510, 570, 1169)
Ability to provide direction to and apply statistical tools
ASQ Certification (CQE, CRE), Six Sigma Black Belt or Green Belt Certification
Leadership skills
Competent in the use of quality tools (ex. Reliability, FMEA, fault tree analysis, root cause analysis, fishbone diagrams, DOE, ANOVA, Cpk, etc)
Working knowledge of MIL specs and NDE methodologies
Min 5 years of demonstrated engineering skills
Demonstrated data-driven decision making