Description
- Evaluate compliance of materials and/or processes with specification and customer requirements.
- Collect, analyze and interpret statistical data.
- Perform defect analysis on components, finished goods and complaints.
- Initiate corrective action requests on discrepant product/processes and verify adequacy and accuracy of corrective action taken internally and/or externally.
- Assist in Design of Experiments to improve process/product.
- Interpret engineering drawings, schematic diagrams, or formulas and confer with engineering staff to determine quality and reliability standards.
- Define a verification/validation process and develop protocols in conjunction with appropriate functions, perform analyses, and document results in a report format consistent with process requirements.
- Mentor and coach other Quality Engineers.
- Assist suppliers in developing inspection methods.
- Perform Gage R&R/MSA's and correlation studies.
- Perform Internal/External Quality System Audits.
- Aid in the management of our subcontract suppliers.
- Provide training and assistance to inspectors.
- Work with QA Technicians to resolve measurement issues.
- Work with QA departments to resolve blueprint/specification issues.
- Develop Control Plans, Inspection Instructions and other documents as needed to effectively manage product/process quality both internally and at the suppliers.
- Develop and review documented operating procedures associated with material inspection or processes.
- Work directly with suppliers to prevent or correct discrepant material.
- Other duties as assigned with or without accommodation.
- Bachelor's of Science in Engineering, Quality Assurance or Life sciences or equivalent work experience.
- 5 years of experience in the medical device industry in a Quality Engineering capacity or equivalent work experience.
- Experience in a regulated environment (FDA, ISO, etc.).
- Blueprint and specification reading, Geometric Dimensioning and Tolerancing.
- Excellent verbal and written communication skills are required.
- Demonstrated proficiency utilizing problem solving tools Six Sigma Tools (i.e., FMEA, DOE, SPC, C & E matrix etc.) and application of statistical techniques is desired.
- Must be comfortable with MS Office Package, Minitab.
- Familiarity with the sterilization methods and biocompatibility testing is a plus.
- Six Sigma training, Certified Quality Engineer and/or Certified Quality Auditor a plus.
To find out more about Real please visit www.realstaffing.com