Quality Assurance Specialist

6 days ago


Bridgeport, Michigan, United States Orchid Orthopedics Full time

About Orchid Orthopedic Solutions

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Orchid Orthopedic Solutions is a leading contract manufacturer of orthopedic devices that enable people to live longer and more active lives. We specialize in implants, instruments, and innovative technologies for joint reconstruction, spine, trauma, sports medicine, extremities, and dental markets.

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Career Opportunities with Orchid

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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 our website.

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Job Description: Quality Engineer II

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We are seeking an experienced Quality Engineer II to play a pivotal role in ensuring the ongoing quality of our products. You will collaborate closely with project management and manufacturing engineers to support the introduction of new production and ongoing validation processes.

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Your Responsibilities:

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  • Continuous Learning: Complete all required training to excel in your role.">
  • Quality Toolbox: Harness 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 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.">
  • Validation Expertise: Plan and execute process and equipment validations.">
  • 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.">
  • 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.">
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Requirements and Qualifications

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To be successful in this role, you should have a degree in a relevant field and significant experience in quality engineering. You must possess excellent communication and analytical skills, as well as the ability to work effectively in a team environment.

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Benefits Package

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We offer a competitive salary range of $85,000 - $110,000 per year, depending on experience, plus a comprehensive benefits package, including performance bonuses, insurance, 401(k) with company match, paid time off, and employee events.

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Location

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This role is based in Bridgeport, MI, with access to our 85,000 sq ft manufacturing facility. As a result, we expect you to be available to work full-time hours, including occasional overtime.



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