Senior Supplier Quality Engineer

Senior Supplier Quality Engineer (Smith & Nephew, Inc., Austin, TX): Develop and implement overall quality plan including master validation plan, process plan, quality control plan, inspection and testing techniques and Statistical Process Control (“SPC”) program. Utilize standard and advanced statistical techniques to determine product acceptance, process capabilities and develop statistically sound tolerance limits. Provide key supplier performance metrics to the department manager, senior management, and key stakeholders. Improve global and site supplier controls procedure requirements as well as modify existing drawings and specifications to improve quality and correct errors. Support customer complaints by assisting in the analysis and development of corrective action and proper documentation of complaint analysis.

MINIMUM REQUIREMENTS:

Must have a Bachelor’s degree in Mechanical Engineering, Bioengineering or Health Sciences plus 5 years of post-baccalaureate experience in the job offered or related role in the medical device industry. Alternatively, the employer will accept a Master’s in Mechanical Engineering, Bioengineering or Health Sciences plus 3 years of experience in the job offered or related role in the medical device industry.

Of the required experience, must have 5 years of experience if qualifying with a Bachelor’s degree OR 3 years of experience if qualifying with a Master’s in each of the following:

 

• Statistical Tools: Minitab and Gd&T.
• Microsoft Applications: MS office, Excel, Visio and Power Point.
• Problem solving using any of the following: A3, DMAIC, 5 Why’s, or 8D
• Regulatory and Notified Bodies Inspection Readiness.
• Manufacturing Processes: assembly, injection molding, extrusion, EO and Gamma sterilization, cleaning, packaging of medical devices, monitoring of class 7 cleanroom environment, and machining of medical devices.

Of the required experience, must have 3 years of experience in Database Management using the following software: Agile, Oracle, SAP, Smartsolve, or Trackwise.

Of the required experience, must have 2 years of experience in each of the following:

• Problem solving such as: Plan Do Check Act (PDCA), Process failure mode and effect analysis (PFMEA) or Corrective and Preventive actions (CAPA)
• Statistical analysis such as: statistical process control (SPC), design of experiments (DOE) or Measurement System Analysis such as Gage repeatability and reproducibility.

Of the required experience, must have 1 year of experience in Production Part Approval Process (“PPAP”).

Domestic and international travel required 25-50% of the time.

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.