1 Message
Digest #1271
Message
Tue Feb 25, 2014 9:35 am (PST) . Posted by:
"john sampson" jcsspike
Sr.Quality Systems Manager Contact:
Janelle Razzino or Mike Butti
Razzino Associates, Inc.
Janelle@razzinoassociates.comMichael@razzinoassociates.com
201-722-3111
Job Location
Job Category QA
Date Posted
A multinational company, a world leader in the development of in-vitro diagnostic reagents and instrumentation. Since its founding in 1959, has led the rapidly evolving markets of clinical diagnostic systems for blood gas and electrolytes analysis, hemostasis, and clinical chemistry. Renowned medical technology is used every day in hundreds of hospitals and laboratories around the globe. It is focus on its customers-and on the patients whose lives are touched by its products-that is guiding the company into the next century.
Responsible for the development and implementation of programs that will
assess, integrate and manage Quality System elements within the facility.
Establishes and maintain programs in compliance with medical device, IVD
and related domestic and international regulations. Supports
multi-disciplinary functions in meeting quality and regulatory compliance
requirements for IL systems, i.e. CE, CSA, European Directives,
Environmental, to meet worldwide regulatory requirements.
•May fulfill the role of the Management Representative to ensure that
processes needed for the quality and environmental managements system are
established, implemented and maintained and report to the Management Review
Committee (MRC) on the performance of these systems for their review and
action, including recommendations for improvement.
•Participates as an EDMA (European Diagnostic Manufacturers Association)
member in Discussion Forums to access information at an early stage on
major EU regulatory issues essential for strategic planning.
•Works with customers to identify projects to improve the quality system
for compliance, efficiency or changing requirements due to Regulatory
changes or organizational / growth needs.
•Facilitates execution of projects to improve the quality systems.
•Assures that systems of responsibility are managed appropriately, provide
added value to the organization and are in compliance with the local and
international standards and regulations.
•Works with management in developing appropriate metrics. Monitors the
health of the Quality System through identification of key metrics. Reports
on the metrics at regularly schedule meetings.
•Develops full project plans for each approved area of integration; reports
to upper management.
•Manages the internal audit system and the corrective/preventive to ensure
continued compliance to domestic and international regulatory regulations.
•Manages the change order system to ensure continued compliance to domestic
and international regulatory regulations and meet production requirements.
•Establishes and coordinates the site quality system training program to
ensure that new personnel are trained to the cGMP and ISO requirements
specific to their job responsibilities and that the existing personnel base
is reviewed annually for additional training needs due to changes in the
regulations and to foster continuous improvement.
•Manages the quarterly cGMP training system and implementation of alternate
training mechanisms for a layered training approach.
•Maintains IL's CSA Category Certificate Program or the Material Safety
Data System. Interfaces with CSA to create and maintain our instrument safety
certification. Performs monthly audits to support safety program and
reviews all changes for impact to our certificates from CSA.
•Audits and evaluates Suppliers on an ongoing basis, maintaining an
approved supplier list. Works with a team (purchasing, engineering and
manufacturing) to support manufacturing goals.
•Quality System Management of: CAPA, Internal and Supplier Audit Programs,
Change Order, Metric preparation, Labeling and Translations, DHF Audits,
Record Retention, QS Training.
•Motivates, trains, and develops personnel in the use of relevant tools and
techniques of the quality disciplines. Institutes contemporary approaches
to division quality objectives.
•Directs the development of quality department expense and capital budgets.
Minimum Skills & Knowledge Requirements:
•Must have an in-depth knowledge of the manufacture and control of medical
devices.
•Bachelor's degree in Engineering, Science or other technical field, or
equivalent experience required. Master's degree preferred.
•Requires a minimum of 5 years in a position of leadership within the
Medical Device Industry.
•Proven ability to manage diverse teams, and implement Quality Improvement
Techniques in the areas of production and new product development arenas.
•Needs good working knowledge and interpretation of foreign and domestic
device regulation.
•Fluency in the use of statistical methods of quality control and data
analysis is required to interact with product/process quality trends.
•Must be familiar with business and financial planning and control
concepts.
•Must be skilled in the use of contemporary quality attainment
methodologies including statistical methods and systems deployment.
•Requires effective interpersonal and negotiating skills.
Janelle Razzino or Mike Butti
Razzino Associates, Inc.
Janelle@razzinoasso
201-722-3111
Job Location
Job Category QA
Date Posted
A multinational company, a world leader in the development of in-vitro diagnostic reagents and instrumentation. Since its founding in 1959, has led the rapidly evolving markets of clinical diagnostic systems for blood gas and electrolytes analysis, hemostasis, and clinical chemistry. Renowned medical technology is used every day in hundreds of hospitals and laboratories around the globe. It is focus on its customers-and on the patients whose lives are touched by its products-that is guiding the company into the next century.
Responsible for the development and implementation of programs that will
assess, integrate and manage Quality System elements within the facility.
Establishes and maintain programs in compliance with medical device, IVD
and related domestic and international regulations. Supports
multi-disciplinary functions in meeting quality and regulatory compliance
requirements for IL systems, i.e. CE, CSA, European Directives,
Environmental, to meet worldwide regulatory requirements.
•May fulfill the role of the Management Representative to ensure that
processes needed for the quality and environmental managements system are
established, implemented and maintained and report to the Management Review
Committee (MRC) on the performance of these systems for their review and
action, including recommendations for improvement.
•Participates as an EDMA (European Diagnostic Manufacturers Association)
member in Discussion Forums to access information at an early stage on
major EU regulatory issues essential for strategic planning.
•Works with customers to identify projects to improve the quality system
for compliance, efficiency or changing requirements due to Regulatory
changes or organizational / growth needs.
•Facilitates execution of projects to improve the quality systems.
•Assures that systems of responsibility are managed appropriately, provide
added value to the organization and are in compliance with the local and
international standards and regulations.
•Works with management in developing appropriate metrics. Monitors the
health of the Quality System through identification of key metrics. Reports
on the metrics at regularly schedule meetings.
•Develops full project plans for each approved area of integration; reports
to upper management.
•Manages the internal audit system and the corrective/preventi
continued compliance to domestic and international regulatory regulations.
•Manages the change order system to ensure continued compliance to domestic
and international regulatory regulations and meet production requirements.
•Establishes and coordinates the site quality system training program to
ensure that new personnel are trained to the cGMP and ISO requirements
specific to their job responsibilities and that the existing personnel base
is reviewed annually for additional training needs due to changes in the
regulations and to foster continuous improvement.
•Manages the quarterly cGMP training system and implementation of alternate
training mechanisms for a layered training approach.
•Maintains IL's CSA Category Certificate Program or the Material Safety
Data System. Interfaces with CSA to create and maintain our instrument safety
certification. Performs monthly audits to support safety program and
reviews all changes for impact to our certificates from CSA.
•Audits and evaluates Suppliers on an ongoing basis, maintaining an
approved supplier list. Works with a team (purchasing, engineering and
manufacturing) to support manufacturing goals.
•Quality System Management of: CAPA, Internal and Supplier Audit Programs,
Change Order, Metric preparation, Labeling and Translations, DHF Audits,
Record Retention, QS Training.
•Motivates, trains, and develops personnel in the use of relevant tools and
techniques of the quality disciplines. Institutes contemporary approaches
to division quality objectives.
•Directs the development of quality department expense and capital budgets.
Minimum Skills & Knowledge Requirements:
•Must have an in-depth knowledge of the manufacture and control of medical
devices.
•Bachelor's degree in Engineering, Science or other technical field, or
equivalent experience required. Master's degree preferred.
•Requires a minimum of 5 years in a position of leadership within the
Medical Device Industry.
•Proven ability to manage diverse teams, and implement Quality Improvement
Techniques in the areas of production and new product development arenas.
•Needs good working knowledge and interpretation of foreign and domestic
device regulation.
•Fluency in the use of statistical methods of quality control and data
analysis is required to interact with product/process quality trends.
•Must be familiar with business and financial planning and control
concepts.
•Must be skilled in the use of contemporary quality attainment
methodologies including statistical methods and systems deployment.
•Requires effective interpersonal and negotiating skills.
No comments:
Post a Comment