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The DHR Reviewer/ Inspector will be responsible for product quality assurance activities. This includes interpretation and implementation of quality standards to routine manufacturing and product release activities.
Job Responsibility:
Develop and maintain strong internal working relationships across restor3d
Understand the objectives, responsibilities, and mission of the Sterility & Lot Release department and work towards those goals
Prioritize and plan work activities
adapt for changing conditions
Review labels for accuracy and precision
Review of Device History Records to perform release of sub-assemblies and finished goods
Inspect finished parts, and materials for conformance to quality control standards
Initiate and participate in resolution of non-conforming materials
Responsible for final product release sign-off
Other responsibilities as assigned
Requirements:
Excellent written and verbal communication skills
Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail
Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness
Strong organizational, analytical, and time-management skills
Able to be self-motivated and work both independently and as part of a team
Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have high attention to detail
Knowledge of FDA and ISO standards for Medical Devices is a plus
Ability to multi-task, perform efficiently, and independently
Nice to have:
Knowledge of FDA and ISO standards for Medical Devices is a plus