Site Quality Manager

4 weeks ago


Santa Ana, California, United States Orchid Orthopedics Full time

About the Role

The Site Quality Manager will be responsible for ensuring compliance and progress towards the established goals of the organization as the quality department head. This includes developing and enforcing quality standards and good business practices, communicating and ensuring customer expectations and regulation requirements are met.

Key Responsibilities

  • Provides daily quality decisions and direction on product-related issues
  • Interface with customers regarding quality concerns topics that include, but are not limited to metrology, inspection techniques, quality paperwork/certifications, and performance scorecards
  • Conceive, present, and lead continuous improvement projects related to Quality Control and Document Control
  • Track and trend internal and external quality metrics to proactively solve problems
  • Participate 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
  • Utilize 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
  • Participate in regular RPN reduction activities linked to the PFMEA process to proactively prevent quality or manufacturing-related problems
  • Lead change efforts to improve internal rework and scrap to improve KPI Metrics
  • Work positively and enthusiastically to promote a Quality culture and engage the organization

Requirements

  • Bachelor (Preferred)
  • Master (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

Additional Requirements

  • Candidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirements
  • Candidates must be able to provide proof of eligibility to work in the United States through eVerify


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