Manager, Process Manager at Capital One leading teams in Customer Protections planning processes. Collaborating in a hybrid environment while managing staffing and process improvements.
About the role
- Quality Process Manager overseeing activities of quality in production at Coloplast. Ensuring compliance with internal/external requirements and managing the complaint handling team.
Responsibilities
- Oversee the activities of quality in the production ensuring standardization across all value streams
- Ensure all activities on the production floor are meeting the internal and external requirements
- Ensure administrative tasks as well as strategic oversight and leadership of Quality Engineers and Quality Assistants in CAR value streams
- Manage the complaint handling team, ensuring synergy between market feedback and production of finished goods
- Support the quality team in production across all value streams, through training, coaching, and guiding lower-level employees
- Communicate quality standards and KPI metrics to the team and other relevant stakeholders
- Manage and optimize processes to ensure compliance with products specifications for quality
- Identify, lead, and implement quality processes including changes to procedures
- Maintain effective quality metrics and define activities to resolve decreases in performance
- Participate in creation of the department objectives for the fiscal year
- Be a role model of 6S, Lean and disciplined problem solving throughout the organization
- Own and manage relevant portion of the Quality budget
- Participate in internal and external audits as an active member
- Conduct formal performance evaluations, provide coaching for development, and hold accountability for team performance
Requirements
- 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)
- 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
Benefits
- Medical insurance
- Asociation
- Gym
- Cafeteria subsidy
- Free transportation
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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