Quality Control Specialist 2021-06
Morton-MN: Altimate Medical is looking for a Quality Control Specialist to Assist with the maintenance of an established Quality Management System (QMS) which conforms to and is compliant with the Food & Drug Administration Quality System Regulation (FDA QSR), ISO 13485 Standard, and other applicable regulations/standards.
Primary responsibility is to assist the Quality Assurance Manager in conducting the final inspection of product. Also, to assist the Quality team with calibration & equipment management, incoming receiving inspection, disposition of non-conforming materials, returns, parts validations, and other items.
Specific Job Duties/Responsibilities:
- Ensuring proper records are maintained appropriately to provide evidence of conformity to requirements.
- Resource Management
- Assist the Quality team to ensure appropriate Infrastructure exists and appropriate records are maintained, and that necessary Work Environment and Contamination Controls are in place to not adversely affect product quality.
- Product Realization
- Assist the Quality Assurance Manager in conducting verification of purchased product (receiving inspection) and maintain records.
- Ensure proper identification (status labels) of incoming components
- Ensure that final product conforms to specification (complete, functions properly, labeled appropriately, etc.) and is clean by performing Final Inspection
- Monitoring and Measuring Equipment
- Assists Quality Assurance Manager, with calibration and maintenance activities.
- Measurement, Analysis, and Improvement
- Non-Conforming Product
- Assist Quality Team with control of Nonconforming product.
- Identify, or assist in the identification/implementation of, process and QMS improvements.
- Non-Conforming Product
- Provide this support across AMHI business units as requested
- Other duties as assigned.
Education and/or Experience:
- High school education
Skills and Abilities:
- Ability to follow procedures and apply to AMHI products and processes
- Ability to read and follow product design prints
- Detail oriented
- Communication skills – oral and written
- Ability to trouble shoot and solve problems
- Ability to work independently.
- Ability to work individually and as part of a team
- Ability to work with teams in multiple locations
- Computer proficiency with Microsoft Office and ability to learn other software
- Thorough product and process knowledge (internal training will be provided)
- Knowledge on use of common hand/power tools and measuring devices