Management Systems Analyst

Main accountabilities and responsibilities (including I Care) 

• An Employee with uncompromised commitment to our I Care journey which ensures a safe, healthy, and sustainable work environment. 

• 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) 

Experience and qualification requirements 

• University Degree in related field 

• 3+ years working experience 

Skills and Competencies 

• 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 

Functional: 

• 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 

• Software validation 

• Design- and change control 

• CAPA 

• QMS related IT systems 

• Language skills, English

Planta Monterrey