Quality Assurance Specialist

3 weeks ago


Torrington CT USA, United States Michael Page Full time
About the Role

We are seeking a highly skilled Lead Quality Engineer to join our team at Michael Page. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality and compliance in our medical device manufacturing processes.

Key Responsibilities
  • Develop and implement validation master plans, protocols, and reports for equipment, processes, and software.
  • Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing equipment.
  • Conduct risk assessments using tools such as FMEA (Failure Modes and Effects Analysis) to identify potential hazards and mitigate risks.
  • Collaborate with cross-functional teams to develop and implement risk mitigation strategies.
  • Identify opportunities for process improvement and implement changes to enhance efficiency and product quality.
Requirements
  • Prior experience with validation protocols (IQ, OQ, PQ).
  • Root Cause Analysis experience.
  • Independent time management and communication skills.
What We Offer
  • Competitive base salary.
  • Bonus potential.
  • Terrific benefits.
  • Growth opportunities for advancement within the organization.


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