Summary of Function:
- The Quality Metrologist (QM) primarily supports the Production and Engineering activities at Medbio, as well as assisting in metrology and auditing activities, while preserving relevant ISO/FDA requirements.
Major Duties and Responsibilities:
- Program and utilize the CMMs to establish and execute part-measurement programs. In this capacity, the QM will interpret all necessary GD&T and drawing dimensions/notes
- Assist in the completion of Mold Qualifications, whether they be for new tools, tool repairs, or process-revision changes
- Perform sample-based inspections to meet incoming, in-process, and release requirements
- Learn and follow ISO/cGMP requirements, ensuring that the procedures and systems at Medbio are in compliance, and maintaining a high level of awareness of the requirements among the employees at Medbio
- Review production documentation, ensuring completeness, accuracy, and compliance of the production records to the SOPs
- The QM reports directly to the Quality Manager. Management, Team Leaders, and Technical staffing can look to the QM for clear resolution to specification and/or part-quality issues.
Experience and/or Educational Requirements:
- Four-year degree or equivalent in years’ experience in Quality-related field
- Two years or more involved in plastic injection molding
- Preferred experience in a medical device manufacturing environment
- Solid understanding of ISO/cGMP requirements with regard to manufacturing and document control
- Good computer skills (Microsoft Office)
- Excellent blueprint reading skills with understanding of GD&T principles
- Very strong written/verbal communication, leadership, interpersonal and motivational skills
- Self-motivation and ability to manage the QM’s portion of complex projects with important deadlines
- Must be able to work a standard 40 hour workweek with occasional overtime including weekends a possibility. Sitting and/or standing for extended periods of time as well as some walking within the facility. Must be able to see with or without corrective lenses and distinguish color differences and depth perception for product and safety issues. Hearing ability should be sufficient to hear and react to audible alarms from distances up to 100 feet. The ability to lift and carry various items up to 50 pounds.