What are the responsibilities and job description for the Quality Engineer position at Medbio, LLC?
Summary of Function:
The Quality Engineer (QE) primarily supports the customers to field any complaints or corrective action requests, and supports Engineering activities at Medbio. The QE will assist in, as necessary, production, metrology, and auditing activities, while preserving relevant ISO/cGMP requirements.
Major Duties and Responsibilities:
The QE reports directly to the Director of Quality Assurance and Regulatory Affairs. Management and technical staffing can look to the QE for clear resolution to specification and/or part-quality issues. Engineering will regularly partner with the QE for measurement systems analysis, risk analysis, or qualification activities.
Experience and/or Educational Requirements:
Must be able to work and perform what would be considered standard practices for this type of position in the industry.
The Quality Engineer (QE) primarily supports the customers to field any complaints or corrective action requests, and supports Engineering activities at Medbio. The QE will assist in, as necessary, production, metrology, and auditing activities, while preserving relevant ISO/cGMP requirements.
Major Duties and Responsibilities:
- Learn and follow ISO/FDA requirements, ensuring that the procedures and systems at Medbio are in compliance; help maintain a high level of awareness of the requirements among the employees at Medbio
- Field any Customer Complaints and Supplier Corrective Action Request (SCARs), and record them in their respective Logs. The QE will work with others in the organization to drive toward root-cause identification and solid, well-documented actions to prevent recurrence
- Assist Engineering in the planning and writing of protocols, and the execution (i.e. evaluation of parts) where necessary
- Assist Engineering in the brainstorming and recording portions of the risk analysis process, including Decision Tree Matrix (for protocols), PFMEA, Process Flow, Control Plans (when requested by the customer), and maintenance of any existing PFMEAs
- Review production documentation and ensure completeness and accuracy, and compliance of the production records to the SOPs. Assist in writing Communication Travelers, as necessary, to clarify or enhance the production specifications
- Create MRBs, as necessary, and assist in the investigations and disposition of suspect material, whether from internal or external sources
- Provide input to all QA-related IQMS procedures and qualification efforts; provide necessary training and training literature for new modules
- Provide backup support to the Director of QA/RA for the review and sign-off of Protocols and Reports, as well as for DCNs, Temporary Deviations, and other related authorizations
- Assist the Director of QA/RA in the review of Mold Qualification results, for dimensional results and/or general paperwork submissions to customers
The QE reports directly to the Director of Quality Assurance and Regulatory Affairs. Management and technical staffing can look to the QE for clear resolution to specification and/or part-quality issues. Engineering will regularly partner with the QE for measurement systems analysis, risk analysis, or qualification activities.
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
- Understanding of ISO/FDA requirements with regard to manufacturing and document control
- Good computer skills (Microsoft Office)
- Good blueprint reading skills; GD&T experience a plus
- Very strong written/verbal communication, leadership, interpersonal and motivational skills
- Self-motivation and ability to manage the QE’s portion of complex projects with important deadlines
Must be able to work and perform what would be considered standard practices for this type of position in the industry.