Quality Process Manager Empleos | Coloplast (Cartago)

Descripción del trabajo

Quality Process Manager will oversee the activities of quality in the production ensuring standardization across all value streams, and that all activities on the production floor are meeting the internal and external requirements. In addition, Quality Process Manager will ensure administrative tasks as well as strategic oversigh and leadership of Quality Engineers and Quality Assistants in CAR value streams. Additionally, Quality Process Manager is responsible for managing the complaint handling team, ensuring synergy between market feedback and production of finished goods.

Responsabilidades

Supporting the quality team in production across all value streams, through training, coaching, and guiding lower-level employees to ensure that they comply with the Quality Management System (CAPA, NC, Change Control, Document Control, Audit, production - and quality procedures etc.)
Communicates quality standards and KPI metrics to the team, and other relevant stakeholders
Manage and optimize processes to ensure that the team complies with products specifications for quality
Identify, lead, and implement quality processes, including changes to procedures, while supporting the integrity of the Quality Management System
Identify continuous improvement opportunities including performing complex analysis and present relevant metrics to stakeholders, as well as supporting and guiding the Quality Engineers to do the same
Maintain effective quality metrics and define as well as execute activities to resolve decreases in performance and continuous quality improvement
Participate in creation of the department objectives for the fiscal year. This includes project plans, training, development, and other specific work plans
Be a role model of 6S, Lean and disciplined problem solving throughout the organization
Own and manage relevant portion of the Quality budget to ensure effective resource utilization
Participate in internal and external audits as an active member and support the team in the preparation of activities
Ensuring optimal training plans for the team, job descriptions, and the right competencies
Conduct formal performance evaluations, provide coaching for development, and hold accountability for team performance
Support the team with data analysis / trend analysis of production data and escalate to Management for evaluation if actions are needed
Understand and mentor statistical knowledge as a working tool to support the team with taking the appropriate decisions
Local coordination of complaint handling process based on the corporate and local instructions, and ensuring compliance of Coloplast Quality Management System
Managing and leading the daily work (incl. training and guiding) of subordinate jobs (Complaint Handler, Complaint Handler technicians)
Supporting the trend analysis of complaint data and investigation of products, provision of data for production and make sure the appropriate actions for improvements are taken
KPI reporting for business and quality monthly and managment reviews
Leading the team to understand the presentation of data for corrective/preventive actions evaluation
Ranking and reporting incident trending towards the local / global quality departments (e.g. Vigilance)
Ensure continued preparedness from the “know-how” of the products / technologies involved
Create, update, document, implement relevant procedures
Participate and represent the Complaint process activities in both internal and external audits
Participate in development of complaint report structure and reporting of targets
Performing their job in compliance with the guidelines given
Drawing attention to the manager to any difficulties in understanding or following the guidelines
Drawing attention to inefficiency of the system
Take responsibility for those safety aspects identified for the given position
Support positive EHS culture
Demonstrating responsibility and promoting EHS and Quality culture
Defining responsibility and authority for EHS work
Ensure that employees receive adequate training
Ensure awareness and complaince of the Quality and Sustainability EHS policy
Ensure awareness of their contribution to the effectiveness of the EHS and Quality system and the environmental performance
Ensure awareness of implications for not conforming with EHS and Quality requirements
Ensure good conditions related to EHS and prevent occupational injuries/diseases as well as environmental incidents

Requisitos

Bachelor's degree in engineering or related field
Minimum 5 years’ experience in Quality Assurance Processes
Minimum 5 years’ experience in medical device industry including device laws & regulations
Minimum 5 years supervisory experience
Solid knowledge and experience working with external quality regulations (ISO, FDA, MDSAP) including hosting external QMS certification audits and Third party audits
Demonstrated and impactful experience with product and process qualification, and validations, process improvement, process control and monitoring (SPC)
Demonstrated experience on nonconformance/non complaint product/ process management
Strong root cause analysis experience, CAPA mentoring and approval, value improvement, risk reduction, and cost containment
Demonstrated organizational influence to include, but not limited to compliance excellence, organizational improvement, product-related risk mitigation, and/or manufacturing cost reduction
Minimum B2+ English
Qualified internal auditor ISO13485

Deseable

Master´s degree
Quality or Lean Certifications (i.e., Six Sigma Belt, ASQ CQE/CRE/CQM)
Continuous Improvement and Lean experience
CAPA expert
Risk Management and Assessment knowledge

Lo que ofrecemos

Medical insurance
asociation
gym
cafeteria subsidy
free transportation

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Quality Process Manager

Descripción del trabajo

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