Major Duties and Responsibilities:
- Assist with responsibilities of any other members of the Quality Department as needed.
- Train Medbio personnel on 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, leading determination of root cause and appropriate corrective action, completing NMR documentation, approving, and escalating to a CAPA when appropriate
- Develop relationships with customers for assigned customers / parts, including at least one major customer
- Show advanced level of understanding of customer parts and applications
- Serve as a member of the Material Review Board (MRB) for assigned customers / parts, frequently 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 customers and 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 writing protocols, executing requirements, and writing reports
- Assist in setting lab priorities and division of responsibilities
- Serve as a resource for basic statistics skills
- Create and analyze statistical experiment plans as needed, including Gage R&R, Measurement System Analysis, Process Study, Tolerance Interval, etc.
- Serve as a resource for part measurement issues, including spec interpretation, measurement techniques, vision system programming, etc.
- Coordinate sample submissions (PPAP, approved samples)
- Approve defect 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
- Lead or participate in supplier audits as requested
- Lead one or more of the following (may participate in multiple):
- Internal Audit program
- CAPA Team
- Monthly Metric preparation
- Intellect module development or modification
- Equipment or Software validation
- Lead major supplier quality issue
- Maintain a professional relationship with all other employees, and develop strong team relationships
- 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
- 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 QE II reports to the Director of Quality. Management, Engineers, Team Leaders, and Technical staffing can look to the QE II for clear resolution to specification and/or part-quality issues. The QE II 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 three to four years of relevant experience required; Advanced degree a plus
- 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
- Advanced understanding of ISO/cGMP requirements with regard to manufacturing and document control preferred
- Good computer skills (Microsoft Office)
- Advanced math skills
- Advanced blueprint reading skills with understanding of GD&T principles preferred
- Moderate understanding of statistics required; Advanced understanding of statistics preferred
- Strong written/verbal communication, leadership, interpersonal and motivational skills
- Self-motivation and ability to manage multiple projects with important deadlines
Physical Requirements:
- Four-year degree (engineering, science, or similar) plus three to four years of relevant experience required; Advanced degree a plus
- 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
- Advanced understanding of ISO/cGMP requirements with regard to manufacturing and document control preferred
- Good computer skills (Microsoft Office)
- Advanced math skills
- Advanced blueprint reading skills with understanding of GD&T principles preferred
- Moderate understanding of statistics required; Advanced understanding of statistics preferred
- Strong written/verbal communication, leadership, interpersonal and motivational skills
- Self-motivation and ability to manage multiple projects with important deadlines