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- Field Service Engineer
- DiaSorin Inc. - Detroit, Michigan
- Biotechnology
- Job Purpose:Provide service/support to customers with regard to instrument maintenance, calibration, troubleshooting and repair. Essential Functions:* Provide service and support to internal and external customers with regard to instrument maintenance and calibration, and instrument troubleshooting and repair* Participate in training processes that are designed to develop a highly skilled workforce capable of delivering results consistent with corporate goals and objectives* Understand and utilize documentation protocols and accurately and legibly complete all documentation on time to (see more)
- Field Applications Specialist
- DiaSorin Inc. - Detroit, Michigan
- Biotechnology
- Job Purpose:To provide instrumentation and assay application expertise to external and internal customers. Perform in-house applications and customer training on applications of existing and new products. Customer technical support including troubleshooting, instrumentation and biochemistry, PC applications support and network interfacing of instrumentation to existing customer LIS systems. Essential Functions:* Provide training, service and support to external customers with regard to assay training, instrument operation, instrument maintenance, instrument calibration and (see more)
- Quality Systems Auditor
- Terumo Cardiovascular Systems Corporation - Ann Arbor, Michigan
- Biotechnology
- Job Title: Quality Systems AuditorProfession: Biotechnology/Pharmaceuticals -> QA/QC and AuditingJob Title Description:Quality Systems Auditor Location:Ann Arbor, MI Division:TCVS Ann Arbor, MI Job Type:Regular Description: Responsible for performing systematic and independent Quality Systems audits of various departments within the corporation and various external organizations including customers and vendors, and assisting with third party and regulatory audits such as ISO and FDA. Responsible for establishing and maintaining the corporate internal audit schedule, retaining the summary (see more)
- Regulatory Affairs Specialist
- Terumo Cardiovascular Systems Corporation - Ann Arbor, Michigan
- Biotechnology
- Job Title: Regulatory Affairs SpecialistProfession: Biotechnology/Pharmaceuticals -> Clinical Development ProfessionalsJob Title Description:Regulatory Affairs Specialist Location:Ann Arbor, MI Division:TCVS Ann Arbor, MI Job Type:Regular Description: Determine current FDA regulatory requirements and strategies for TCVS and Terumo Corporation projects. Defines information and actions necessary to meet these requirements. Prepares documents and or submissions required to obtain clearance or approval from government agencies for commercial distribution of products worldwide. 1. Maintains (see more)
- Regulatory Affairs Project Manager
- Perrigo - Grand Rapids, Michigan
- Biotechnology
- Job Title: Regulatory Affairs Project ManagerProfession: Biotechnology/Pharmaceuticals -> QA/QC and AuditingThe ANDAs/NDAs submissions group in Regulatory Affairs has an immediate opening for a Regulatory Affairs Project Manager for ANDAs/NDAs. The ANDAs/NDAs submissions team is responsible for working with many groups in the Company and with FDA for the filing and approval of Perrigo's new drug applications. Responsibilities include (but are not limited to): Assemble and review data and information required for new drug application submissions and amendments. Includes (see more)
- Quality Assurance Specialist
- Terumo Cardiovascular Systems Corporation - Ann Arbor, Michigan
- Biotechnology
- Job Title: Quality Assurance SpecialistProfession: Biotechnology/Pharmaceuticals -> QA/QC and AuditingJob Title Description:Quality Assurance Specialist I Location:Ann Arbor, MI Division:TCVS Ann Arbor, MI Job Type:Regular Description: This position is responsible for investigating, planning, and implementing the improvements in and/or additions to quality and manufacturing processes with the end result of producing a better quality product more efficiently. Ensure compliance to Terumo's quality policy, respond to customer complaints, perform audits, develop test methods, and/or write (see more)
- Clinical Studies Specialist
- Terumo Cardiovascular Systems Corporation - Ann Arbor, Michigan
- Biotechnology
- Job Title: Clinical Studies SpecialistProfession: Biotechnology/Pharmaceuticals -> Clinical Development ProfessionalsJob Title Description:Clinical Studies Specialist Location:Ann Arbor, MI Division:TCVS Ann Arbor, MI Job Type:Regular Description: Position is responsible for providing clinical, technical, and educational support to assist with Company sponsored clinical device trials. 1. Maintain and follow proper compliance and quality systems requirements, GCP, and all applicable regulations. 2. Clinical and Technical Support: Represents Terumo CVS during surgeries of products to (see more)
- QA Specialist II
- Terumo Cardiovascular Systems Corporation - Ann Arbor, Michigan
- Biotechnology
- Job Title: QA Specialist IIProfession: Biotechnology/Pharmaceuticals -> QA/QC and AuditingJob Title Description:QA Specialist II Location:Ann Arbor, MI Division:TCVS Ann Arbor, MI Job Type:Regular Description: This position is responsible for investigating, planning, and implementing the improvements in and/or additions to quality and manufacturing processes with the end result of producing a better quality product more efficiently. Ensure compliance to Terumos quality policy, respond to customer complaints, perform audits, develop test methods, and/or write procedures as required. 1. (see more)
- Supplier Quality Engineer I
- Terumo Cardiovascular Systems Corporation - Ann Arbor, Michigan
- Biotechnology
- Job Title: Supplier Quality Engineer IProfession: Biotechnology/Pharmaceuticals -> QA/QC and AuditingJob Title Description:Supplier Quality Engineer I Location:Ann Arbor, MI Division:TCVS Ann Arbor, MI Job Type:Regular Description: The Supplier Quality Engineer (SQE) works as the quality liaison between Terumo and our suppliers, providing guidance on product and component quality requirements; generating accurate and timely supplier quality data, trends, metrics and related reports; and determining and monitoring the effectiveness of corrective and preventive actions to resolve (see more)
- Manager, Quality Assurance
- Terumo Cardiovascular Systems Corporation - Ann Arbor, Michigan
- Biotechnology
- Job Title: Manager, Quality AssuranceProfession: Biotechnology/Pharmaceuticals -> QA/QC and AuditingJob Title Description:Manager, Quality Assurance Location:Ann Arbor, MI Division:TCVS Ann Arbor, MI Job Type:Regular Description: This position is responsible for directing and managing quality assurance, test, and document control functions within the respective manufacturing facility. This position must maintain full compliance to all FDA, ISO, and International Quality requirements and maintain efficient in the process and improving of product quality. This individual is the Management (see more)
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