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Philips Global Multi-Vendor Services Quality Specialist Germany, Hesse 702100941
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Job Description
Assist in process mapping and process improvement initiatives by partnering with management and staff to streamline operational workflow
Assist in Complaint/CAPA investigations Provide Internal/External audit support: Including, preparation, participation, performing audits (training provided) and audit defense by managing the “back room”
Support special projects/work related tasks as assigned.
You are responsible for
Assist with Document Control activities supporting Global Multi-Vendor Services policies, procedures, and forms by assisting the current Training Systems Administrator
Assist with local-level employee training on Q&R related topics and as well as maintenance of training records in the TEDS Training Management System
Assist with Quality plan creation, management, and implementation
Assist with Management Review Meeting Preparation
Support the Global Multi-Vendor Services Supplier Management program as required.
Other duties as necessary
You are a part of
Global Multi-Vendor Services has presence in both North America and Europe, with plans for the expansion of its scope as it focuses on third party parts, services, and training. Two current subsidiaries, AllParts Medical and AGITO Medical, have ISO 13485:2016 certified Quality Systems, with more ISO certifications planned.
This position may be based either within Europe or the United States of America.
To succeed in this role, you should have the following skills and experience.
Must possess an engaging personality and positive attitude, ready to be flexible and tackle any project in a fast paced, rapid growth environment.
2+ years of experience in a strong Quality System Environment with a minimum of 2 years in a Medical Device company or other highly regulated Industry.
Experience with Quality methods and tools.
Experience with FDA/ISO related quality process audits
Experience with of automated process management tools.
Experience in working within a large-scale functional matrix organization desired.
Experience in working with a Training Management System or E-Learning tools preferred.
Familiarity of the following medical device related quality & regulatory standards (not all-inclusive): FDA 21 CFR 820, ISO 13485/ISO 9001, ISO 14971, EUMDR, etc.
Must possess superior Time Management, Project Management, Communication and Presentation skills
When faced with a problem or challenge, the Quality Specialist brings creative solutions to the table within the guidelines of the applicable regulations (an Out-of-the-Box thinker).
Must be a driver for facilitating change in the organization
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