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Management Systems Analyst. An Employee with uncompromised commitment to our I Care journey which ensures a safe, healthy, and sustainable work environment.
Job Responsibility:
Act as Role Model for Safety and Quality
Maintain the quality management system for on-going compliance with international medical device related laws and standards, and company/business policies and procedures as applicable
Prepare standard operating procedures, work instructions and forms
Participate in the internal audit program
Support external audits / inspections
Set-up and provide training to the organization to ensure appropriate quality awareness and capability building on all levels
Provide input to the regular site management review
Handling of product complaint, perform complaint investigations
Prepare customer feedback analysis statistics and Post Market Surveillance plans/reports
Is a role model and accountable for performance & consequence management, coaching and education within their department.(if applicable)
Requirements:
University Degree in related field
3+ years working experience
Safety awareness
Leadership & influencing skills
Decision making
Conflict management
Effective communication skills
Presentation skills
Prioritization
Time management
Delegation
Advanced problem-solving skills
Stakeholder management skills
Financial awareness
Analytical skills
Customer focus
Interpersonal skills
Learning agility
Coaching skills
Strong understanding of regulatory requirements (laws and standards), GMPs
Application of modern quality tools, statistical methods, root cause analysis, FMEA
Auditing (internal / supplier), lead auditor qualification