Head of QC US
INTEGRA Biosciences Corporation is an industry leader in innovative liquid handling products for the medical diagnostics, pharmaceutical, biotech, and food industries.
The Head of QC US is responsible for a customer and market-oriented quality system of continuous review and harmonization with INTEGRA Switzerland.
Responsibilities Management of and continuous review and evaluation of the QMS further development Harmonization of processes with INTEGRA Switzerland Checking and approval of internal/external quality-related documents Coordination of system and product-related corrective and preventive action (CAPA) Recognition of weak points in the procedures, processes and process-supporting IT systems - initiation of improvement measures together with responsible process owners and department heads based on:
Inputs and observations from meetings The findings from audits (customer audits, certification body audits, internal/external audits) The analysis as part of the preparation of an annual Management review (ISO 9001:
2015 section 9.
3.
2) The findings from the annual self-assessment of the process management system (ISO 9001:
2015 section 9.
3.
3) Creation and implementation of the Q-relevant processes, evaluation and commissioning of appropriate measurement tools and the associated software:
Continuous Improvement Process (CIP) Coordination with Environmental Health and Safety (EHS, ISO14001) where needed supplier evaluation quality inspection quality data evaluation Active participation in departments with quality related tasks Management of planning, implementation and evaluation of internal audits Preparation and implementation of training courses Supervision of the process control of defective products (NC, 8D, 5W etc.
) Investigate and implement ideas for quality improvement, increased productivity and cost reduction.
Defines manufacturing performance standards and reviews the outcome of performance goals to set future targets at Management Review Controls the Supplier Management program working closely with suppliers to ensure that all components meet department quality standards and on-time delivery goals.
Qualifications Technical studies with specialization in quality management as well as several years of professional experience and first managerial experience Very good knowledge of spoken and written English Experienced handling of Office programs (Word, Excel) Experience with ERP and CAQ systems e.
g.
Unipoint, SAP, INFOR and Calibry preferred Communicative and open-minded Active and independent processing of assigned tasks Readiness for internal and external further training Willingness to travel (.
Estimated Salary: $20 to $28 per hour based on qualifications.
The Head of QC US is responsible for a customer and market-oriented quality system of continuous review and harmonization with INTEGRA Switzerland.
Responsibilities Management of and continuous review and evaluation of the QMS further development Harmonization of processes with INTEGRA Switzerland Checking and approval of internal/external quality-related documents Coordination of system and product-related corrective and preventive action (CAPA) Recognition of weak points in the procedures, processes and process-supporting IT systems - initiation of improvement measures together with responsible process owners and department heads based on:
Inputs and observations from meetings The findings from audits (customer audits, certification body audits, internal/external audits) The analysis as part of the preparation of an annual Management review (ISO 9001:
2015 section 9.
3.
2) The findings from the annual self-assessment of the process management system (ISO 9001:
2015 section 9.
3.
3) Creation and implementation of the Q-relevant processes, evaluation and commissioning of appropriate measurement tools and the associated software:
Continuous Improvement Process (CIP) Coordination with Environmental Health and Safety (EHS, ISO14001) where needed supplier evaluation quality inspection quality data evaluation Active participation in departments with quality related tasks Management of planning, implementation and evaluation of internal audits Preparation and implementation of training courses Supervision of the process control of defective products (NC, 8D, 5W etc.
) Investigate and implement ideas for quality improvement, increased productivity and cost reduction.
Defines manufacturing performance standards and reviews the outcome of performance goals to set future targets at Management Review Controls the Supplier Management program working closely with suppliers to ensure that all components meet department quality standards and on-time delivery goals.
Qualifications Technical studies with specialization in quality management as well as several years of professional experience and first managerial experience Very good knowledge of spoken and written English Experienced handling of Office programs (Word, Excel) Experience with ERP and CAQ systems e.
g.
Unipoint, SAP, INFOR and Calibry preferred Communicative and open-minded Active and independent processing of assigned tasks Readiness for internal and external further training Willingness to travel (.
Estimated Salary: $20 to $28 per hour based on qualifications.
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