Senior Quality Engineer

Work Flexibility: Hybrid or Onsite

What you will do:

• Customer complaint handling
• Should be able to document, review, evaluate and investigate responses on product complaints
• Performs collective analyses of product complaints and reports for trends and identification of potential corrective or preventive actions
• Ensures timely investigation of and response to product complaints. This involves initiating and participating in investigations and corrective action arising from product complaints.
• Collaborates with team members to do complaint investigations

What you need:

Required-

• Good analytical and problem-solving skills; Proficient computer skills in Excel and Word.
• Knowledge of DFMEA/PFMEA/Control plan/7QC tools; 4D problem solving methodology.
• Experience:: 4-6 years; 2-3 years of relevant work experience; Bachelors in Mechanical/Biomedical/Biotech Engineering.
• Experience is 7 QC tools - Fish Bone Diagram, Pareto Charts, and Root Cause Analysis.
• Good understanding of database management of complaint records.
• Prior experience using complaints processing software

Preferred-

• Excellent analytical skills and interpersonal communications skills.
• US FDA quality regulations 21CFR part 820; ISO 13485 standards; NC/CAPA process.
• Trackwise and windchill knowledge

Travel Percentage: Up to 25%