Senior Quality Engineer
JOB SUMMARY: The Continuous Improvement Quality Engineer will work primarily with Volcano’s Quality Operations teams in support of product and process compliance to established procedures and will take corrective and preventive action based on trends. This position will initiate process improvements within receiving and final inspection areas in support of Lean, Six Sigma initiatives resulting in increased business efficiency and effectiveness. Lean manufacturing discipline will play a key role in continuously driving business process efficiency and effectiveness.
RESPONSIBILITIES:
Conduct product and process analysis and takes corrective action as appropriate based on performance results from trends, run-charts, audits or other sources quality data.
In conjunction with Volcano Engineering teams establish/maintain component failure modes, severity, effects, likelihood of occurrence (FMEA) and risk mitigation strategies.
Develop and implement efficient ‘Lean’ processes in support of short and long range quality assurance goals. Provide training to as appropriate to Quality Assurance and Volcano personnel.
Routinely report to management on the health of Quality Control processes and products.
Where applicable, implement statistical process controls (SPC) relative to inspection activities.
As necessary, performs other duties as required.
EDUCATION:
Requires a Bachelor’s degree in engineering disciplines. Mechanical Engineering preferred.
KNOWLEDGE AND EXPERIENCE:
Requires 5 – 8+ years experience in quality assurance/control process application relative to high volume manufacturing.
A working knowledge and practical application of Lean manufacturing, Quality Function Deployment (QFD), Six Sigma, Kaizen, Cost of Quality (COQ) and/or Kanban strongly preferred.
Experience with defining, interpreting and classifying quality characteristics for new products and processes
Relative to Receiving Inspection, a working knowledge of technical drawings that may include mechanical dimensioning and Geometric Dimensioning and Tolerancing (GD&T)
Knowledgeable of the application of Repeatability and Reproducibility (Gage R&R) studies.
A working knowledge of Acceptance Sampling that includes sampling concepts (e.g. operating characteristics (OC) curves, acceptable quality limit (AQL), lot tolerance percent defective (LTPD), etc.).
A working knowledge of Sampling standards and plans (e.g. ANSI/ASQ Z1.4 and Z1.9)
A working knowledge of Measurement System Analysis (MSA) (i.e., Calculate, analyze, and interpret repeatability reproducibility (Gage R&R) studies, measurement correlation, capability, bias, linearity, etc.)
Strong analytical skills with a working knowledge of statistical methods and the use of standard quality tools (e.g. flowcharts, Pareto charts, cause and effect diagrams, control charts, scatter diagrams, regression analysis, affinity diagrams, etc).
A working knowledge of structured problem solving utilizing statistically based decision-making, relationship between variables (e.g. Analysis of variance, Hypothosis testing), value stream mapping, continuous improvement, process and performance capability assessment (CpK) and Design of Experiment techniques.
Ability to work effectively in a highly matrixed organization.
A working knowledgeable of FDA regulations, Quality System Regulations (QSR), ISO 13485 requirements.
LICENSES AND CERTIFICATIONS:
Certified Quality Engineer and/or Certified Reliability Engineer preferred.
Green Belt, Black Belt certification preferred.
ADDITIONAL DESIRABLE QUALIFICATIONS:
Ability to think creatively (outside-the-box)
Ability to commit to a course of action even if there is disagreement with that chosen action.
Lean and Six Sigma tool mastery
Demonstrated capability to lead change through effective interpersonal, communication and leadership skills.
Ability to be self directed with the proven ability to rapidly adjust to new environments.
PHYSICAL REQUIREMENTS:
Capable of lifting 20lbs from floor to above shoulders.
TRAVEL REQUIREMENTS:
Some travel may be required but not anticipated at this time.
Interested candidates should apply online at:
http://www.volcanocorp.com/careers/available-positions.asp
EEO/AA M/F/V/D
