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Manufacturing Engineer - Equipment & Facilities
Eingestellt von Edelway
Gesuchte Skills: Engineer, Sap
Projektbeschreibung
Manufacturing Engineer - Equipment & Facilities
Edelway is a Swiss Professional Services Consultancy. One of our best clients, a global pharmaceutical company based in the Bern/Basel area, is currently looking for a Manufacturing Engineer with experience in Equipment German is a plus.
THE ROLE
*With oversight from the Core Team Leads, determine and report on the state of compliance of the quality system versus regulatory standards (ISO, FDA, etc.)
*Audit sites' inspection Plan to the standards and report out on findings (both current state and retrospectively)
*Make recommendations to achieve compliance where shortfalls are found
*Provide Audit reports as directed
*Consultancy and guidance of all employees and manager regarding manufacturing and facility and operational practices
*Training of all involved employees along the manufacturing and facility process
*Consultancy and guidance of all employees regarding Risk Management
*Bringing in of improvement proposals, which increase the productivity and efficiency of manufacturing and facility and operational practices
*Consultancy and guidance of all employees regarding maintenance
YOUR PROFILE
*Minimum of 5 years experience as manufacturing engineer ideally medical device industry.
*Compliance experience in the medical device is a plus
*Familiarity and interaction experience with regulatory auditing bodies preferred
*Documented training in FDA QSR, ISO 13485/9001 required
*Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines
*Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS SAP etc.)
*Proficient in the use of spreadsheet software (Access/Excel etc.)
If it sounds like your next challenge, send us your CV and we will contact you shortly to discuss it further.
Edelway is a Swiss Professional Services Consultancy. One of our best clients, a global pharmaceutical company based in the Bern/Basel area, is currently looking for a Manufacturing Engineer with experience in Equipment German is a plus.
THE ROLE
*With oversight from the Core Team Leads, determine and report on the state of compliance of the quality system versus regulatory standards (ISO, FDA, etc.)
*Audit sites' inspection Plan to the standards and report out on findings (both current state and retrospectively)
*Make recommendations to achieve compliance where shortfalls are found
*Provide Audit reports as directed
*Consultancy and guidance of all employees and manager regarding manufacturing and facility and operational practices
*Training of all involved employees along the manufacturing and facility process
*Consultancy and guidance of all employees regarding Risk Management
*Bringing in of improvement proposals, which increase the productivity and efficiency of manufacturing and facility and operational practices
*Consultancy and guidance of all employees regarding maintenance
YOUR PROFILE
*Minimum of 5 years experience as manufacturing engineer ideally medical device industry.
*Compliance experience in the medical device is a plus
*Familiarity and interaction experience with regulatory auditing bodies preferred
*Documented training in FDA QSR, ISO 13485/9001 required
*Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines
*Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS SAP etc.)
*Proficient in the use of spreadsheet software (Access/Excel etc.)
If it sounds like your next challenge, send us your CV and we will contact you shortly to discuss it further.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
SAP Entwicklung, Ingenieurwesen/Technik