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Senior Manager, Complaint Handling - Hybrid
StrykerUnited Statesfull_timeVerifiedPosted 3 Jul 2024
About the role
Work Flexibility: Hybrid
Senior Manager, Complaint Handling – Hybrid
Weston, FL
As a Senior Manager, Complaint Handling you will lead a team that conducts and leads failure investigations on customer complaints, which will identify root cause and corrective/preventive actions. You will ensure timely closure of complaints to comply with FDA requirements. You will perform trend analysis and identify negative trends to target for improvement.
Who we want:
- Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner.
- Metrics-oriented managers. People who are always tracking important business metrics to ensure projects meet expectations and budget.
- Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity
What you will do:
- You will provide support to the new product development and risk management process, including FMEA and reliability testing.
- You will ensure timely, accurate and complete documentation of failure investigations of product complaints, leading to root cause and corrective/preventive action.
- You will perform trend analysis, identify trends, and determine/ implement corrective action.
- You will participate in the Product Surveillance Review Board, presenting complaint trends and recommendations for corrective action and product improvement.
- You will participate in and lead continuous improvement and process re-engineering projects as required in support of continuous improvement initiatives.
- You will perform engineering and statistical analysis to access test results, determine trends, probability of failure, root cause and corrective action.
- You will supervise and coach a team of Engineers to achieve team metrics, department objectives and organizational goals; mentor and provide technical training to colleagues.
- You will create individual Learning and Development plans for direct reports and perform mid-year and year-end performance reviews for direct reports.
What you need:
Required
- Bachelor of Science or Engineering or related disciple
- 10+ years’ experience leading failure investigations, design, and/or manufacturing within regulated environment
Preferred
- Master’s degree
- Experience supervising/managing a Quality or Reliability Engineering team.
- Significant knowledge of regulatory requirements: ISO 9001 or ISO 13485, Quality System Regulation 21 CFR 7, 803, 806 and Medical Device Directive
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