Director, Quality job in Billerica, MA

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Matthew Masterson
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Director, Quality job in Billerica, MA

Overview:
As one of the world’s leading analytical instrumentation companies, Bruker covers a broad spectrum of advanced solutions in all fields of research and development. All our systems and instruments are designed to improve safety of products, accelerate time-to-market and support industries in successfully enhancing quality of life. We’ve been driving innovation in analytical instrumentation for 50 years now. Today, worldwide more than 6,000 employees are working on this permanent challenge, at over 70 locations on all continents.

The Director, Quality Systems is responsible for the evolution and improvement of the Quality Management System (QMS) necessary to ensure the highest quality, reliability, and regulatory compliance of products and services delivered. This applies to all activities of the BDAL Division which are driven in and out of the Billerica, MA location.

Responsibilities:
ESSENTIAL DUTIES AND RESPONSIBILITIES: include the following. Other duties may be assigned.
Develop and implement quality management strategy and plans, including resources, systems, schedules, and budget, to support and integrate within the division’s annual business plan and long term strategy.
Develop and maintain systems to meet external quality requirements relating to products and services. These requirements include: U.S. 21 CFR 820 (FDA QSR), ISO 9001, and ISO 13485.
Support of production and release of In Vitro Diagnostic and Research equipment and consumables according to appropriate regulations.
Assure appropriate design controls for design changes and new product introduction according to appropriate regulations...cont.
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