Monday, December 2, 2013

Quality Systems Specialist

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Quality Systems Specialist

Position Description:

This person will also interface with all BBMI sites to ensure systems and processes are properly implemented and maintained for sustained compliance, as well as ensure quality and regulatory compliance requirements are identified, documented, integrated, and maintained to avoid gaps and ineffectiveness.

The essential functions of this role -
•      Solid understanding of the efficiencies and criticalities of all of the quality systems elements at. Work seamlessly with functional business groups to improve upon vertical and horizontal system interfaces and efficiencies.
•      Execute the strategic direction for Quality Systems Excellence Programs & Deployment Management. Understand quality and regulatory requirements and integrates these within the company’s Quality Management System in accordance with system capabilities. Evaluate and implement system and process improvements to ensure that quality systems continue to meet regulatory requirements and expectations.
•      Partner with Quality Operations at all BBMI sites on quality objectives related to quality systems and processes. Serve the Quality project leader and centralized team member for these initiatives. Ensure that user requirements are properly defined and documented, systems are structured to meet established requirements, and training is effectively executed to all affected personnel prior to implementation.
•      Utilize Lean and Six Sigma approaches to quality system processes to ensure processes are not only compliant but also efficient and effective. Must be able to lead Kaizen events with diverse team members to achieve desired results within established time frames.
•      Implement and maintain the Corporate Operating Procedures and centralized processes and templates, identifies and implements process improvement tools for Quality Systems to ensure the process requirements of Quality Compliance systems integrated.
•      Create standard informatics methods for introducing, updating, tracking and trending Quality Systems Metric. Provide standard capabilities for storing information relevant to programs for which Quality Compliance is accountable.
•      Analyze metrics and informatics to monitor the BBMI quality system and its compliance across all sites. Identify system and process issues, concerns or improvement opportunities and leads resolution.
•      Responsible for executing the long-term strategy of the Company’s Quality Systems, incorporating best practices while maintaining alignment to Company Objectives.
•      Ensure that the Company’s Quality System policies and procedures are developed, implemented and maintained in compliance with regulatory requirements (FDA, CGMP, QSR, ISO, CMDR, MDD, etc).
•      Keep informed of all existing and new regulatory requirements and works with Quality Operations to ensure full compliance in the Company’s Quality Systems.

To qualify for this position, candidate must possess the following:
--B. S. in Scientific discipline
--8+ years of developing Quality systems infrastructure or centralized processes experience in the medical device / pharmaceutical industry
--5+ years experience in a quality leadership role required
--Experience in FDA inspections and strategy, cGMPs and an ability to interpret regulatory requirements
--Ability to understand and evaluate end-to-end value streams (R&D, supply chain, product realization, PLM)
--Demonstrated track record in managing a diverse staff and establishing a clear, strategic direction
--Ability to proactively identify and anticipate risk of non-compliance in a dynamic environment
--Project Management experience is required, including project initiation, team development, and achieving desired results on time and on budget.
--Leadership in partnering with Operations, R & D, Engineering, Sales and Marketing.
--Ability to use sound scientific judgment in management of the facility to prevent regulatory action
--Experience building virtual teams globally and enterprise wide with the different business and functional groups and quality operations partners.Get started and apply now!
How to Apply
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HR Executive
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