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%

R541389