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Job Description
- Overview: The Operational Excellence team here at Q Medical is the team that drives for continuous improvement and leads the non-standard/routine initiatives that are needed in order to attain Operational Excellence. This particular role on the team has a focus on ensuring that ISO13485 requirements are being executed in an effective and efficient manner. This position reports directly to the Production Manager.
Responsibilities:
- Perform internal audits of the manufacturing processes to ensure that they match the written process instructions
- Assist in the documentation of manufacturing processes in such a way that reduces operator variability
- Ensure that all manufacturing processes are verified and proven to yield quality products or subcomponents
- Manage Bills of Materials (BOMs) for all products produced and ensure that they are kept up to date
- Document all product issues that are discovered through customer feedback and through internal quality inspections, and oversee the Corrective and Preventative Action process for the issues
- Work with the different managers and Human Resources to oversee the development of operations and management personnel
- Document and improve the company’s standard operating practices
Job Requirements
- Excellent conversational and interpersonal skills
- Understanding of ISO 13485/9000/22000 practices
- Previous experience of internal audits of ISO related practices
- Excellent documentation skills
- Ability to perform moderately advanced operations on Microsoft Excel
- Ability to use Microsoft Word/PowerPoint
- Self-driven individual with the ability to impact change on an organizational level
- Educational Requirements: 4 year degree in Business Administration, Scientific, or Industrial Engineering field.
- Previous Experience Needed: At least three years of experience working on a Quality Assurance team of a large corporation with sophisticated operating practices.