| For more than 25 years, Boston Scientific has advanced the practice of less-invasive medicine by providing a broad and deep portfolio of innovative products, technologies and services across a wide range of medical specialties. These less-invasive medical technologies provide alternatives to major surgery and other medical procedures that are typically traumatic to the body. In less-invasive procedures, devices are usually inserted into the body through natural openings or small incisions and can be guided to most areas of the anatomy to diagnose and treat a wide range of medical problems. |
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| Boston Scientific's mission is to improve the quality of patient care and the productivity of health care delivery through the development and advocacy of less-invasive medical devices and procedures. This is accomplished through the continuing refinement of existing products and procedures and the investigation and development of new technologies that can reduce risk, trauma, cost, procedure time and the need for aftercare. |
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Job Purpose:
Processes the awareness and ability to apply the correct principals,
ethics, guidelines and procedures to access Quality Systems.
Demonstrates the appropriate expertise to assess quality activities in
accordance with regulations, standards and business strategies. Ability to
clearly communicate technical and compliance related information verbally and
in writing to ensure the intended audience understands the potential impact of
the information. Understands, interprets, and applies Documentation Control
principles and processes to ensure compliance with Corporate, FDA, MDD,
ISO regulations and standards with unyielding integrity.
Key responsibilities:
• Read, interpret, develop and implement policies, procedures and protocols
in compliance with regulations and internal corporate policies
• Understand and utilize problem solving methodologies. Evaluate and
recommend continuous improvements opportunities
• Proactively perform audits and evaluate system processes and make
corrections when applicable
• Effectively summarize results of audits and quality system aspects for
site management
• Maintain applicable Corporate wide (quality) systems and reporting
processes at the European Distribution Center
• Actively support Corporate wide projects in relation to the European
Distribution Center
• Guide and prepare and follow up site level external audits
• Interpret, apply and implement (new) regulations, standards and Corporate
policies/procedures and ensures implementation within the European
Distribution Center organization
• Coach others in the appropriate application of standards and regulations
and assure implementation of best practice quality program and policies
• Identify and implement issues and opportunities for improvement within
existing quality and documentation system and drives resolution
• Demonstrate competence in all transaction processes related to
documentation
• Maintain, control, revise and update of the documentation system
implemented at the EDC and to ensure compliance with all Corporate
documentation and applicable standards and ensure incoming documentation
and/ or data complies with Documentation Control Policies and Procedures
• Assure MMR Q-reporting and advice (in- and externally) about Q-issues |
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• Education level: HBO level or a minimum of 3 years BSC business process
experience
• Good knowledge of English in writing and speaking (Dutch is an asset)
• Must be computer literate. Proficient use in current versions of Excel, Word,
Power Point and Visio preferred
• Good analytical, social and communication skills
• Critical, accurate, flexible and stress-resistant
• Familiar with quality tools and technique
• Taking initiative and creativity are a must
• Knowledge of both the medical or pharmaceutical industry and logistics is
an asset.
• Knowledge of applicable regulations (FDA, MDD, ISO)
Personal skills:
• Drives Innovation and Change
• Inspires Others
• Optimizes Communication
• Takes Initiative
• Promotes Teamwork
• Develops Self and Others
• Manages Execution |
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| Mevrouw L. (Linda) Vermeeren |
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