Site Quality Manager

3 weeks ago


Orange, California, United States Orchid Orthopedics Full time
About Us

Orchid Orthopedic Solutions is a world-leading medical device contract design and manufacturing company that offers a comprehensive portfolio of services for implants and instruments. With significant experience in the joint reconstruction, spine, trauma, dental, and sports medicine markets, we provide a unique combination of expertise and innovation.

Job Summary

We are seeking a highly skilled and experienced Site Quality Manager to join our team. As a key member of our quality department, you will be responsible for ensuring compliance and progress towards established goals. You will develop and enforce quality standards and good business practices, communicate and ensure customer expectations and regulation requirements are met.

Key Responsibilities
  • Provides daily quality decisions and direction on product-related issues
  • Interfaces with customers regarding quality concerns, including metrology, inspection techniques, quality paperwork/certifications, and performance scorecards
  • Conceives, presents, and leads continuous improvement projects related to Quality Control and Document Control
  • Tracks and trends internal and external quality metrics to proactively solve problems
  • Participates in internal and/or external audits to ensure compliance to procedures and regulatory requirements
  • Assists in the Nonconformance and Corrective and Preventive Action (CAPA) processes to ensure timely responses to quality issues
  • Utilizes One Orchid global processes to meet Key Performance Indicators (KPIs) for Quality that support Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD), and facility financial objectives
  • Participates in regular RPN reduction activities linked to the PFMEA process to proactively prevent quality or manufacturing-related problems
  • Leads change efforts to improve internal rework and scrap to improve KPI Metrics
  • Works positively and enthusiastically to promote a Quality culture and engage the organization
Requirements
  • Bachelor's degree in a relevant field (preferred)
  • 5+ years of experience in Quality (required)
  • 5+ years of experience in a Leadership Role (required)
  • 2+ years of experience in a Leadership Position in a Manufacturing Environment (preferred)
  • 8+ years of experience in Quality (preferred)
  • 5+ years of experience with Quality Systems in a Highly Regulated Industry (i.e. Medical Devices, Aerospace, Pharmaceutical, Food, or Nuclear) (preferred)
What We Offer

Opportunity to work in a growing company

Ability to help people live a longer, more active life

Comprehensive benefit package

Ability to work in an organization that values:

  • Integrity First: We do the right thing
  • Teamwork: We are one Orchid
  • Results: Our results matter

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