Sr. QE Operations

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.