What are the responsibilities and job description for the QC Inspector I position at Nihon Kohden Orange Med?
Job Purpose
As QC Inspector I, you will be a contributing team member who will be responsible in supporting various aspects of quality control.
Duties and Responsibilities
Perform routine inspections of incoming, in process, and finished products for correct identification, traceability, and conformance to approved specifications.
Determine acceptability of raw materials, components, and subassemblies according to standards and internal requirements.
Generate nonconforming material reports, and track status of nonconforming material reports to determine product release status.
Support process validation by assisting in protocol execution, data compilation, and coordinating validation activities.
Support internal and external audits and prepare documentation accordingly.
Review all quality documents for accuracy and completeness. Notify appropriate individuals if corrections are needed.
Document, archive, and maintain all inspection records, device history records, and all other quality documents.
Promote continuous improvements by suggesting revisions to appropriate work instructions and procedures relevant to the role. Engage in the effort to identify and propose implementation actions to improve Quality Management System.
Navigate, generate quality records, and/or perform transactions on NKOM electronic QMS and ERP systems.
Perform other related quality functions as required by management.
Qualifications
A minimum of 4 years of relevant experience and a high school diploma.
Demonstrates basic knowledge of Quality Management System and current Good Manufacturing Practices (cGMP).
Demonstrates strong verbal, written, and interpersonal communication skills.
Ability to use handheld measuring devices such as calipers, rulers, micrometer, etc.
Ability to work effectively in a team environment.
Basic computer skills which include the use of Microsoft WORD and EXCEL.
Possesses basic knowledge and skills on navigating, generating quality records, and/or performing transactions on electronic QMS and ERP systems.
Desirable Accreditations/Knowledge
Hands on experience with mechanical ventilators
Working Conditions
A QC Inspector I works in an office environment and Manufacturing area.
A QC Inspector I works a standard work week but may be required to work some evenings and weekends to meet the needs of the company.
Physical Requirements
Must be able to type using the keyboard of a computer. Must be able to talk, listen and speak clearly on the telephone. Must be able to lift and carry up to 50 lbs.
