BS degree in Science, Engineering, Materials or Mathematics preferred from an accredited college or university.
Advanced degree a plus.
Six Sigma and Lean training and/or experience is a plus.
ASQ Certification is a plus.
MS Office Applications, Power Point, SharePoint, PowerLink, MAPICS, MS Project.
Certifications, Licenses, Registrations.
Current Passport - for travel to Mexico facility as required.
Prefer Lean Manufacturing and Six Sigma Green Belt.
Complaint investigation, validation support, development of inspection plans, failure analysis, testing, gauging, vendor management issues, and statistical process control.
Work with management on quality planning (both long and short term) supporting diagnosis of quality problems ( both internal and external), corrective and preventative action programs and continuous improvement programs.
New Product and Development Process, Design Reviews and all aspects of Design Control, including, but limited to Quality Planning, FMEA, Control Pans, Hazard Analysis, Biocompatibility, sterilization, and packaging/shelf life studies activities.
Define deliverable quality requirements as input to project plans
Material Review Board (MRB) process (Purchased materials and in-house manufactured product).
Identify non-conformance trends and develop and administer technical investigation and corrective action programs to resolve recurring quality problems and to improve vendor quality.
Prepare Vendor QA/Inspection protocols.
Utilize standard statistical analysis techniques to determine product specifications. Participate in vendor site audits and work with suppliers to improve quality of both delivered parts and internal quality processes.
Develop, validate, document and refine QA Test and Inspection procedures.
Select and acquire equipment /tooling as required.
Evaluate and recommend QA sampling plans based on desired confidence limits, process capabilities, and manufacturing/inspection methods and equipment.
Develop Process Validation Master Plans and IQ, OQ, PQ, PPQ Protocols.
Define sampling plans with statistical rationales, process control plans, and apply SPC to mfg applications.
Monitor and lead improvements based on the evaluation of results.
Provide technical guidance and training to other team members in statistical analysis techniques, experimental design, data analysis, sampling techniques and other traditional QA engineering areas of expertise and lean tools.
Provides direction in the completion of projects by displaying excellent interpersonal skills and completing projects according to specified time lines.
Support Company Strategies as required.
Travel as required to perform the objectives and end results of this function.
Perform other related duties as may be reasonably assigned in the course of business.