Senior Quality Engineer

Description

• Perform quality planning.
• Read and interpret blue prints and specifications to develop and maintain Quality Inspection Plan and other documents that are part of the Orchid Quality System.
• Work with customer representatives to determine and document customer dimensional and cosmetic acceptance criteria and inspection methods where they are not clearly defined by the customer.
• Complete quality plan for each project.
• Create and maintain PFMEA's and Control Plans.
• Create and perform GR&Rs, correlation studies and capability studies as needed.
• Write, update and improve quality procedures and work instructions as required.
• Assist QA and with qualification and validation of new projects. Review written and executed protocols as required
• Performs containment, root cause analysis, corrective action, review and reporting for customer returns and complaints.
• Follow quality system requirements associated with returns and complaints.
• Assist engineers with the conceptualization and development of part fixtures to hold parts during inspection.
• Assist in mentoring quality and production personnel on problem solving and proper inspection techniques.
• Adhere to established ISO 13845 and FDA requirements.
• Adhere to established safety practices and follow safe work practices.
• Maintain company, customer and supplier confidentiality.
• Use Minitab or other software to analyze data (capability studies, Gage R&R, ANOVA, etc.) and create report/validation materials
• Support continuous improvement as a change agent for internal rework and scrap and process optimization.
• Communicate with suppliers and customers to address concerns and resolve issues.

• Must be familiar with inspection of complex parts with tight tolerances using advanced measuring and layout techniques. Must be able to perform inspection using basic techniques.
• Must possess the ability to apply the fundamental quality tools (Pareto charts, cause and effect diagrams, 5-Why analysis) to define, analyze, and solve problems.
• Must have excellent blueprint reading skills and thorough knowledge of Geometric Dimensioning & Tolerancing (GD&T) and the application of AMSE Y14.5M.

• Bachelor's degree and 2 - 5 years of previous experience or equivalent in education and experience.
• medical device manufacturing experience preferred.