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Senior Quality Engineer

Cytiva

Shrewsbury, MA
8 days ago
97,800 - 155,000

Job Description

Join Cytiva as a Senior Quality Engineer and make a significant impact in life sciences and biotechnology. You will oversee quality management systems, drive compliance, and collaborate with cross-functional teams to support projects that enhance human health.

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 business functions
  • Lead or support quality and compliance projects

Required Qualifications

  • Bachelor’s degree
  • At least 8 years relevant industry experience (e.g. GMP medical device, pharmaceutical)
  • At least 5 years relevant QMS experience
  • Extensive experience with cGMP and/or ISO 13485
  • Excellent verbal, written, and presentation skills

Preferred Qualifications

  • Experience with supporting change control systems (ECR / ECO)
  • Experience with risk management (FMEA)
  • Analyzing and processing data with statistical tools
  • Experience working with cross-functional teams

Benefits & Perks

Paid time offMedical/dental/vision insurance401(k) planBonus/incentive pay