Major Duties and Responsibilities:
- Assist with responsibilities of any other members of the Quality Department as needed.
- Train Medbio personnel on basic quality documents and processes
- Develop relationships with other departments with the goal of instructing and communicating quality requirements to ensure a high quality product and compliance to all aspects of the Quality Management System
- Nonconforming material report (NMR) activities including tracing nonconforming conditions back to their origin, confirming containment activities properly segregated potentially non-conforming material, determining root cause and appropriate corrective action, completing NMR documentation, approving, and escalating to a CAPA when appropriate
- Develop relationships with customer for assigned customers / parts
- Develop understanding of customer parts and applications
- Serve as a member of the Material Review Board (MRB) for assigned customers / parts, occasionally leading team efforts
- Serve as customer contact for discrepant product issues identified at the customer or at Medbio
- Work with customer to solve any specification concerns during development and after release to production
- Work with project engineers to determine and execute the quality planning process through to product launch and any changes once products have been released to production
- Communicate with customers regarding changes in manufacturing methods (CIMMs)
- Participate in equipment and software validation and mold qualification as needed, including executing requirements
- Assist in setting lab priorities and division of responsibilities
- Serve as a resource for basic statistics skills
- Create statistical experiment plans as needed, including Gage R&R, Measurement System Analysis, Process Study, etc.
- Serve as a resource for part measurement issues, including spec interpretation, measurement techniques, vision system programming, etc.
- Coordinate sample submissions (PPAP, approved samples)
- Support business development for new and existing customers when opportunities exist
- Complete all required documentation, legibly and accurately, on paper and electronically in computer systems using proper grammar
- Complete documentation (batch record) review related to FDA regulated medical devices and components as outlined in “product release” planning sheets
- Develop and maintain ISO and FDA compliant quality documents related to products and quality processes, including inspection plans, work instructions, traveler documentation, SOPs, and forms. Assist other departments with their documents.
- Perform and analyze process capability and tolerance interval studies, determining course of action for any outlier, unexpected, or failing results. Write reports and communicate to customer, receiving approval as needed.
- Lead or participate in internal audits and support external audits as requested
- Participate in supplier audits as requested
- Lead minor supplier quality issue or participate as team member for major supplier quality issue
- Maintain a professional relationship with all other employees
- Keep a clean and orderly work area, including proper filing and maintenance of QA documentation and samples
- 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
- Work to achieve Monthly Company goals and metrics
- Function as a designate for the Director of Quality or other Quality Engineers as requested; typically only if no more senior member of the quality team is available
- Perform other tasks assigned by the Quality Manager and/or Director of Quality
- Maintain work habits and safety procedures according to company policy, standard operating procedure, and quality manual
- Support and adhere to Medbio’s Corporate Mission and Core Values
- Perform other duties as assigned
Organizational Relationships:
- The QEI reports to the Director of Quality. Management, Engineers, Team Leaders, and Technical staffing can look to the QEI for clear resolution to specification and/or part-quality issues. The QEI interacts with management, engineers, maintenance, operators, assemblers, suppliers, and customers regarding all aspects of part and process quality.
Experience and/or Educational Requirements:
- Four-year degree (engineering, science, or similar) plus zero to two years of relevant experience or equivalent in years of experience in Quality related field required
- Certified Quality Auditor, Certified Quality Engineer, or Six Sigma Black Belt Certification a plus
- Preferred experience in a medical device manufacturing environment or similarly regulated environment
- Solid understanding of ISO/cGMP requirements with regard to manufacturing and document control preferred
- Good computer skills (Microsoft Office)
- Advanced math skills
- Moderate blueprint reading skills with understanding of GD&T principles preferred
- Moderate understanding of statistics required
- Solid written/verbal communication, interpersonal and motivational skills
- Self-motivation and ability to manage projects with important deadlines
Physical Requirements:
- 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 30 pounds required
- Pass drug and physical screenings