Marcial Armas
Service Center Manager @Werfen North America
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WORK HISTORY
Service Center Manager @Werfen North America
San Diego, CA, US
Provide technical and process leadership for repair and evaluation of returned products within an FDA-regulated Service Center environment for medical deviceso Review failure investigation reports and provide support to the Quality organization for preventative actions (CAPA) and complaint investigation processo Develop methods, processes, procedures, and equipment that will improve the failure investigation process, reduce failures in the field, and improve customer experience.• Establish, measure and report on key quality metrics to drive quality and operational excellenceo Created an accurate and consistent method of KPI delivery working cross-functionality with management and Data Analysts• Develop and execute Service strategies to ensure KPI targets, quality standards, and timelines are met• Work cross-functionally with Quality Engineering, Instrument Manufacturing, Technical Support, Quality, Regulatory Affairs, Marketing, and Sales, to track and trend data trends, updates, and improvements• Drive and maintain engagement through consistent team member development and performance feedback.• Responsible for trending and analysis of Post Market Surveillance product datao Report key data to members of executive suite and colleagues• Create and maintain project timelines where buy-in is needed from cross-functional partners and persuasion of others is used to influence outcomes• Create, update, and maintain complex protocols, technical reports, Service Manuals, and other technical documents to ensure compliance with Quality Assurance and ease of use for users. • Encourage cross-functional collaboration and a sense of ownership from my team• Work closely with international and domestic affiliates on customer complaints and repairs
EDUCATION
California State University San Marcos
BSc, Management Information Systems
SKILLS
ABOUT MARCIAL ARMAS
Medical Device industry veteran with over 10 years of experience in progressively increasing leadership roles. Specialized knowledge in 21 CFR Part 820, ISO 13485, and QMS continuous improvement. Led on-site and fully-remote teams in complex Medical Device Report submission (100k+/yr with over 99.95 on-time percentage) and recently, in Diagnostic Medical Device repair, Quality Investigations, and Service Operations continuous improvement. Able to work collaboratively, competently, and productively with Quality, R&D, Regulatory Affairs, Manufacturing, Human Resources, and Customer Support functions. Comfortable and confident in external and internal audits as a result of being the sole representative of my department in various audits. Encourage accountability and professional-growth for direct reports through tactfully-delivered feedback, accountability, and career placement.
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