Quality Engineer

1 week ago

Bridgeport, United States Orchid Orthopedics Full time

ABOUT US Orchid Orthopedic Solutions is a contract manufacturer of orthopedic devices that serve to enable a longer and more active life. Orchid specializes in implants, instruments and innovative technologies for the following markets: joint reconstruction, spine, trauma, sports medicine, extremities and dental. Orchid's largest manufacturing facility is located in Bridgeport, MI. This 85,000 sq ft facility specializes primarily in cutting tools for orthopedic, dental and trauma markets. Our core products include burs, pins, screws, drills, reamers, and saw blades for both implants and instruments. A career with Orchid provides training and growth opportunities, a great benefits package, including performance bonuses, insurance, 401(k) with company match, paid time off and employee events. For more information, please visit SHIFTNo Shift ($0) (United States of America) A BRIEF OVERVIEW As a Quality Engineer II at Orchid, you'll play a pivotal role in ensuring the ongoing quality of our products. You'll collaborate closely with project management and manufacturing engineers to support the introduction of new production and ongoing validation processes. WHAT YOU WILL DO Continuous Learning: You'll start by completing all the training required to excel in your role. Quality Toolbox: Harness the power of quality tools such as process flowcharting, Pareto analysis, correlation and regression analysis, and more to drive improvements in our processes Customer Champion: Act as a liaison between Orchid and our valued customers, ensuring that their quality concerns are addressed effectively. Data-Driven Insights: Utilize statistical methodology to collect, analyze, and present data that informs critical decisions. Supplier Support: Assist suppliers in interpreting and meeting quality requirements. QMS Excellence: Contribute to the development of essential Quality Management System (QMS) deliverables and Advanced Product Quality Planning (APQP) processes, including complaint analysis, risk analysis, and CAPA. Validation Expertise: Plan and execute process and equipment validations, including IQ, OQ, and PQ. Customer Collaboration: Work closely with customers to clarify their requirements, ensuring our processes align with their needs. Process Capability: Determine machine and process capability through planning and executing Process Capability studies. Precision Inspections: Develop inspection criteria that connect customer requirements with manufacturing processes, including key characteristics and sampling plans. Innovation Advocate: Lead and conceive productivity improvements and continuous improvement projects. Quality Assurance: Monitor engineering production processes for adherence to internal and external standards. Product Launch Support: Participate in pre- and post-production launch reviews, providing crucial quality engineering support. Audit Excellence: Perform quality reviews and internal audits, translating data into actionable insights. Continuous Improvement: Recommend modifications to existing quality and production standards for optimal quality within equipment capabilities Change Management: Review and approve product/process and document change requests. Technical Expertise: Scrutinize drawings for quality requirements, geometric dimensioning and tolerance, process and material specifications, and key characteristics. Performance Monitoring: Collaborate with cross-functional teams to measure and analyze key metrics to drive performance improvements. Safety Advocate: Reinforce safety expectations, ensuring safe operating practices are followed, and promptly report concerns to your supervisor. Quality and Compliance Champion: Support quality and compliance by adhering to all procedures, work instructions, and forms per the Quality Management Systems (QMS). EDUCATION QUALIFICAT

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