M-F, 7:30am-4pm
14-month initial contract
*Experience is medical, or manufacturing fields is preferred.
Description:
The Quality Engineer I is responsible for supporting the Quality Management Systems. The Quality Engineer I will ensure that the Regulations, Standards and Guidelines are complied with ensuring that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act). Must have mechanical experience: read blueprints and know specs.
30%
Works with area teams to implement continuous quality improvement programs which may include: vendor certification for ship to stock; design of experiments to identify and control process variables; quality systems improvement projects; and installation of statistical and non statistical process controls.
30%
Assists area teams to maintain applicable regulatory compliance which may include new hire orientation training, internal and external QSRs and CAPA.
10%
Leads the review, disposition, and corrective action activities associated with discrepant components, materials, sub-assemblies and finished products.
10%
May ensure that quality reporting (e.g. incoming and in-process quality trends; returns analysis, categorization and corrective action activity, etc.) is maintained and documented with the assigned team.
10%
Leads the review of standard and non-standard analysis evaluation of issues such as the internal audit program, CAPA, materials review and complaint analysis.
10%
Other duties, as assigned.