Quality Process Manager

This is a permanent position to work in our Cartago site, located in Zona Franca La Lima. Medical insurance, asociation, gym, cafeteria subsidy, free transportation and other, are part of our benefits package.

Job function summary
Quality Process Managerwill 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,. 

Major areas of accountability 

•    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 and mentor statistical knowledge as a working tool to support the team with taking the appropriate decisions. 

Complaint handling process
•    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

Responsible for:
•    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

Essential Qualifications:
•    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 onnonconformance/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

Prefer qualifications:
•    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

Con unos ambiciosos planes de crecimiento, Coloplast desarrolla y comercializa productos y servicios que hacen la vida más fácil a aquellas personas con necesidades de cuidados sanitarios especiales. Tenemos más de 16 000 empleados y nuestros productos están disponibles en más de 143 países. Somos una de las empresas líderes de dispositivos médicos a nivel mundial. Constantemente buscamos nuevas formas de hacer crecer el negocio : exploramos, aprendemos y buscamos nuevas formas de hacer las cosas.

Coloplast se compromete a ser una organización inclusiva, donde las diferencias son bienvenidas, las personas desarrollan su potencial y tienen un fuerte sentido de pertenencia debido a  _ no a pesar de_ sus diferencias. Por ello animamos a todos los candidatos idóneos y cualificados a presentar su candidatura independientemente de su sexo, edad, raza, nacionalidad, etnia, orientación sexual, creencia religiosa o capacidad física.

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