- Locations: Illinois, California, Massachusetts, New York, Pennsylvania
- Quality Engineer
- ThinkEnergyGroup.com (Round Lake, IL)
- ...to test -> Provide Quality oversight and guidance to project teams in area of responsibility, assuring compliance to procedure -> Review DHF and DMR documents and other records for the Quality function, including VandV, Risk Management, etc Requirements: -> 3-5 years working...
- Product Development Engineer
- Executive Recruiting Firm (Alameda, CA)
- ...risk . Develop and manage R&D design processes for orthopedic joint surgical processes, directing others to create & maintain DMR, DHF and appropriate documentation Follow QSR to develop and perform testing, test methods and apparatus for evaluating the safety and reliability...
- DHF Remediation Specialist
- Edwards Lifesciences (Midvale, UT)
- DHF Remediation Specialist Req #: 3759 City: Midvale State: Utah Country: USA Function: Quality...a temporary/contract opportunity for appproximatly 1 year. Create project schedule to complete DHF remediation and reports against schedule. Work with teams and across departments...
- Project Manager, OEM
- Olympus (Southborough, MA)
- ...changes and interventions to achieve timely project outputs * Manage the Design History File ( DHF ) for OEM product launches by: - Ensuring compliance to FDA regulations for proper DHF file creation and maintenance - Coordinating cross functional teams including Marketing, Research and...
- OEM Project Manager
- Gyrus/Olympus (Framingham, MA)
- ...manage project changes and interventions to achieve timely project outputs Manage Design History File ( DHF ) for OEM Product Launches Ensure compliance to FDA regulations for proper DHF file creation and maintenance Coordinate cross functional teams (Marketing, R & D, Regulatory,...
- Manufacturing Process Engineer
- BeyondTek IT (Minneapolis, MN)
- ...a€ cents Certifications/ Engineering: ASQC a€ cents Design Controls, DHF , and Engineering Documentation a€ cents ISO 9000, 9001, 9002...Engineer, Solidworks: please specify Total exp of Design Controls, DHF , and Engineering Documentation: please specify Do you have Certifications/...
- Project Manager, OEM
- Olympus America Inc. (Southborough, MA)
- ...changes and interventions to achieve timely project outputs * Manage the Design History File ( DHF ) for OEM product launches by: - Ensuring compliance to FDA regulations for proper DHF file creation and maintenance - Coordinating cross functional teams including Marketing, Research and...
- Quality Engineer
- GCR (Marlboro, MA)
- ...areas of risk management, DFMEA, test method validation, specification/sample plan criteria, design verification/validation, process validation and DHF organization/content Review OEM documentation to verify alignment of the marketing/product specifications and ensure overall compliance of...
- Program Manager - Pumps, TMSW and or Accessory Products
- Medtronic (Northridge, CA)
- ...groups, aligning priorities to achieve a common end goal . Responsible for the creation and maintenance of the Project File / ( DHF ) . Insure project deliverables meet requirements (Regulatory, Corporate, Notified Body and UL as Required) Basic Qualifications . Bachelor's degree (B. A....
- Principal Quality Engineer
- Baxter (Waukegan, IL)
- ...technical closure, and investigations of customer complaints as part of CAPA and continuous improvement processes. .Support Quality input to DHF /risk remediation activities .Participate in compliance audits Job Requirements * BS in Engineering plus minimum 5 years relevant experience...
- Sr Manager, Quality Engineering
- Baxter (Waukegan, IL)
- ...Action processes * Support global Renal manufacturing facilities and associated manufacturing and supplier changes * Provide Quality input to DHF /risk remediation activities * Support internal and external quality audits and FDA inspections * Implement continuous improvement in products...
- Quality Mgr - Medical Device
- TDC Medical Inc. (Sunnyvale, CA)
- ...(CAPA), change control and notification, internal and vendor audits, product release, document control, design control process and design history files ( DHF ), device master records, etc. * Manage the resources of the Quality Department to ensure staff are selected and sufficiently trained...
- Quality Engineer
- ThinkEnergyGroup.com (Round Lake, IL)
- ...cycle to ensure compliance -> Assist Project teams to identify compliance risks during the product development cycle -> Review and approve DHF and DMR documents and other records for the Quality function, including VandV, Risk Management, etc -> For the Risk Management you...
- Principal Quality Engineer
- Baxter HealthCare (Mcgraw, NY)
- ...closure, and investigations of customer complaints as part of CAPA and continuous improvement processes.· Support Quality input to DHF /risk remediation activities· Participate in compliance audits Job RequirementsBS in Engineering plus minimum 5 years relevant experience preferred, OR...