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
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
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