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Posted by: CCSI Inc - Robert Ryder <robert@ccsiinc.com> on October 12, 2009 at 14:31:37. Click here to reply to this post via Email.

Contract / Temp to Perm / Permanent: Contract
City: Mounds View
State: Minnesota
Country: United States

Design history file review to collect, review, and update as necessary, risk assessment and Design FMEA documentation on existing market released devices, Confirm and document traceability between objective evidence documentation and MDD Conformity requirements., Generate Declaration of Conformities., Confirm and document traceability between objective evidence documentation and EN IEC 60601-1 standard requirements and all relevant standards.

Design history file review to collect, review, and update as necessary, risk assessment and Design FMEA documentation on existing market released devices, Confirm and document traceability between objective evidence documentation and MDD Conformity requirements. Generate Declaration of Conformities., Confirm and document traceability between objective evidence documentation and EN IEC 60601-1 standard requirements and all relevant standards. Diagnostic and therapeutic medical devices and device programmers., Provide support for released products, evaluate field performance and recommend corrective action when necessary., Prepare, review and approve Qualification Test Plans and Reports for assigned projects., Review and approve changes to products in production for reliability impact to aid in the correction of process, design or materials problems., Support Materials Quality Engineering by providing reliability input in the evaluation of discrepant material and in the qualification of new material to assure that device reliability requirements are met., Support Regulatory Affairs by providing reliability input in the evaluation of MDRs and submissions of requests for approval to the FDA, Investigates and evaluates product field problems. This includes preparing Product Field Impact Reports and Health Hazard Analysis and working with Marketing, Product Development and Regulatory on field action plans.