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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
Apply Online
Apply Here By Choosing Multiple Job Codes
Warm Regards
HR Executive
Customer Is King
Web : http://customeriskinginc.com
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