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Senior Quality Engineer

Disability Solutions

Miami, FL
19 days ago
97,800 - 155,000

Job Description

Join Cytiva as a Senior Quality Engineer and drive improvements in quality management systems while collaborating with cross-functional teams. Contribute to impactful projects that enhance life sciences and biotechnology solutions.

Key Responsibilities

  • Act as a subject matter expert for Change Management/Change Control process
  • Establish and maintain site/business unit level processes and procedures
  • Collaborate with stakeholders across several business functions
  • Lead or support quality and compliance projects

Required Qualifications

  • Bachelor’s degree required
  • At least 8 years relevant industry experience (e.g. GMP medical device, pharmaceutical)
  • At least 5 years relevant QMS experience dealing with investigations, CAPA, change control, risk management
  • Extensive experience with cGMP and/or ISO 13485 including documentation, audit, nonconformance and CAPA
  • Excellent verbal, written, and presentation skills in English

Preferred Qualifications

  • Experience with supporting change control systems (ECR / ECO) and risk management (FMEA)
  • Analyzing and processing data with various statistical tools
  • Working with cross-functional teams and facilitating solutions to complex problems

Benefits & Perks

Comprehensive benefits package including paid time offMedical/dental/vision insurance401(k) plan