Quality Engineer II

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.
• Show advanced level of understanding of customer parts and applications.
• Serve as a member of the Customer Focus Team (CFT) for assigned customers / parts, frequently leading team efforts.
• 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).
• Work with customers 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.
• Participate in equipment and software validation and mold qualification as needed, including writing protocols, executing requirements, and writing reports.
• Aid in setting lab priorities and division of responsibilities.
• 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.
• Cook up 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): 26.1. Internal Audit program 26.2. CAPA Team 26.3. Monthly Metric preparation 26.4. Intellect module development or modification 26.5. Equipment or Software validation.
• 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 Quality Manager or other Quality Engineers as requested.
• Perform other tasks assigned by the Quality Manager.
• 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 Quality Manager.
• 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) preferred.
• Advanced math skills preferred.
• 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 preferred.
• Self-motivation and ability to manage multiple projects with important deadlines preferred.