Summary of Function:
- The Lead Metrologist supports Engineering activities at Medbio Inc, including Product/Process Qualification/Validations, engineering studies, product development reviews. The Lead Metrologist will be responsible for training Quality Technicians and Quality Inspectors in metrology practices. The Lead Metrologist will assist in identifying new metrology equipment needs and leading improvement teams to improve the process of measurement, data storage, and reporting. This person will also support others areas of the organization in the areas of calibration, and auditing activities, while adhering to relevant ISO and cGMP, and FDA regulatory requirements.
Major Duties and Responsibilities:
- Support Engineering in drawing reviews for metrology-related concerns and/or identify any metrology-related equipment or fixturing needs
- Assist Engineering in the planning and writing of protocols, and the execution where necessary
- Works with Quality Engineering to develop and execute validation of new metrology equipment
- Support Engineering on the prioritization and completion of qualification activities
- Work with Engineering on Mold Qualification, Engineering Studies, Measurement System Analysis (Gage R&R), and other measurement-related activities
- Support metrology activities for complex project launches with important deadlines
- Develop robust layout plans for new parts, ensuring utilization of proper measurement tools
- Train and develop Quality Technicians and Quality Inspectors on the proper and consistent use of metrology equipment
- Develop and document relevant measurement procedures
- Assist in the development/improvement of data-enabling systems
- Data Collection
- Data Storage
- Programming File Management and Control
- Serve as the backup person for monthly internal calibrations, and facilitate the scheduling, transportation, and return of all externally-calibrated devices
- 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
- Interact with Management, Engineers, Maintenance, Supervisors, Team Leaders, Operators, and Customers, to resolve part- and process-related issues
- Perform other tasks assigned by the Quality Manager or Vice President of QA/RA
Organizational Relationships:
- The Lead Metrologist reports directly to the Quality Assurance Manager. Management, Supervisors, Team Leaders, and Technical Staffing can look to the Lead Metrologist for clear resolution to specification and/or part-quality issues. Engineering will regularly partner with the Lead Metrologist to assist with blue print interpretation, potential fixturing designs, and in problem resolution both internally and externally. The Lead Metrologist will work closely with the Quality Technicians and Inspectors as well as manufacturing in order to develop and improve metrology-related practices.
Experience and/or Educational Requirements:
- Four-year degree or equivalent in years’ experience in Quality-related field is preferred
- Five years or more involved in plastic injection molding is preferred
- Five years or more experience in CMM and/or other software-operated metrology equipment
- Experience in a medical device or pharmaceutical manufacturing environment is preferred
- Solid understanding of ISO and FDA regulations and cGMP requirements
- Good computer skills (Microsoft Office)
- Excellent blueprint reading skills with strength in GD&T principles
- Very strong written/verbal communication, leadership, interpersonal and motivational skills
- Self-motivation and ability to manage the Lead Metrologist’s portion of complex projects with important deadlines
Physical Requirements:
- Must be able to work a standard 40 hour workweek with occasional overtime, including weekends as a possibility. Sitting and/or standing for extended periods of time as well as some walking within the facility. Must have 20/20 vision with or without corrective lenses and be able to 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. Must be able to lift and carry various items up to 50 pounds.