Zug, Zug, Switzerland
Merger and acquisitions cultural change management Talent management in attract, develop and retain Drives and manages the quality strategy, focusing on the continuous improvement of the quality system, remediation, and integration in global organizations Interacts internally and externally with executive level management, outside vendors, customer vendors/supplier and outside regulatory agencies Over 20 years of work experience in the medical device field
Have been transferred from Japan to Switzerland for improve collaboration and partnership between different organizations global due to non-communication and nontransparent work environment. Lead and implement the product lifecycle management software system. Quality management representative of legal manufacturer for R&D, manufacturing, distribution and field activity. Manage budget and monitor any irregularities. Remediation and integration of legal manufacturing into Abbott cooperation. Define company strategy with supply chain, R&D and operation to provide best product to the customer and patient and keep the company as a high innovation, reliability and profitability place. Responsible for multiple projects though whole quality areas. Manage culture change at the site and integrated the acquired site to the Abbott organization. Responsibility for quality engineer/validation, supplier quality, design/development quality, quality control and quality system and regulatory compliance departments.
• Drives and manages the site Quality strategy, focusing on the continuous improvement of the Quality System and its integration of the site within MCS and Abbott • Enables professional and on-time communication with all relevant stakeholders and internal and external customers with respect to Quality System and Regulatory Compliance of the site processes • General oversight and responsibility for the Quality System processes • Provides high level direction and strategy for site and Quality Department to maintain and improve the status of compliance to external and internal requirements and regulations, standards and laws • Final responsibility for decisions on Product quality • Plans and manages Quality department budget in alignment • Very strong exchange and aligned communication with Site Director on site strategy • Oversees and guides development of Quality team • Oversees all aspects of the production quality assurance and document control activities to ensure compliance with internal procedures and regulations • Manages the activities of the Quality organization with responsibility for results in terms of product quality, performance and safety • Responsible for providing support and communication with Operations and customers to resolve quality issues and other related product concerns • Actively drives all defined Quality Systems goals and objectives at the plant level • Quality management representative for legal manufacturer
• Establishing, implementing and maintaining Quality Management System in Abbott Japan by providing leadership of Quality function. (Design, Implementation, Auditing and Continual Improvement): • Effective communication and engagement with all other departments to facilitate their engagement and execution of quality-focused, compliant activities. • Handling and managing QMS external audits, Notified Body Audits, supplier audits • Quality Assurance of new product development process activities meeting required industry and regulatory standard for devices. • Managing WHO, US Government, cGMP, GxD and ISO guidelines and quality systems. Product complaints, validations, CAPAs, labeling controls, product release. • Creating a Quality Excellence habit and environment • Quality management representative for legal manufacturer
CORE COMPETENCES • Excellent technical understanding of manufacturing equipment and processes • Highly knowledge ISO 13485 and ISO9001 • Strong multilingual communication skills: Daily business in German and English • International works experience with leading in a multi-national environment Conduct investigation, bounding, documentation, review and approval for recall. Escalation of quality issues as appropriate. Review root cause investigation according to an established process. Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits. - Communicated on a daily basis with Depuy Synthes Europe and the United States to resolve challenges including logistics, compliance issues, general quality questions, recalls and delivery stops - Investigate product releasing report from the operating company and summarize for the Japan market - Explanation manufacturing processes for the GQP committee to make final decision of the recall - Manufacturing validation process training for local employee - Lead transfer projects and improvement projects (CIP) - QMS Quality Management Submission - FMR Foreigner Manufacture Registration - Lead quality and change projects - Coaching and training quality employee - Manage Operating Company investigation for Japan
Accountable for the oversight and execution and maintaining of Quality Management Systems and Compliance at the Selzach global DC in accordance with Q&C requirements and customer needs. Managed customer complaints and followed through with contacting suppliers in order to achieve corrective action. Lead quality projects among multiple manufacturing facilities which included developing risk management procedure jointly with suppliers. Communicated on a daily basis with Depuy Synthes Japan, Europe and the United States to resolve challenges including logistics, manufacture and compliance issues, and general quality questions. • Investigates for CAPA’s and also effectively monitors and defines tasks for CAPA’s • Wrote procedures on country specific labeling and trained personnel on how to correctly use procedures • Creates all work orders, procedures, NCR documents, and process documentation from German to English • Investigated worldwide customer complaints for all departments within Johnson & Johnson • Creating and reporting Matrix and quality reviews • Oversees delegation for Quality employees and internal quality team • Member of lead Kaizen projects • Leading the core team of the Quality Management
• Validation OQ and PQ • Carried out validation and statistical analysis on procedures • Trained mechanical engineers on procedures for measurement machines • Released to the market First Article Inspection (FAI) documents • Performed internal audits • 3D Measurement CNC machine • Creating best Kaizen work place at manufacture side
• Assembled medical devices • Inbound and outbound inspection of supplies • Non conform report • Lot release • Responsible for new employee introduction and training
CNC DNC 8 axes trun round machine 5 axes milling machine Training employees and students Prototyp surgery instruments Programmer new DNC programs