Quality Assurance Engineer

6 days ago


Seabrook, New Hampshire, United States Katalyst Healthcares and Life Sciences Full time
Job Summary

We are seeking a highly skilled Manufacturing Engineer to join our team at Katalyst Healthcares and Life Sciences. As a key member of our product development team, you will be responsible for ensuring the quality and reliability of our medical devices.

Key Responsibilities:
  • Client Relationship Management: Develop a deep understanding of our clients' methods and procedures to ensure seamless collaboration and delivery of high-quality products.
  • Protocol Development: Utilize client templates and protocols to develop and implement effective qualification and validation processes for software components.
  • Collaboration and Communication: Work closely with our Quality Assurance team to obtain reviews and approvals of work packages, ensuring that all deliverables meet the highest standards.
  • Test Execution and Reporting: Support the execution of test scripts and develop comprehensive summary reports to facilitate informed decision-making.
  • Continuous Improvement: Identify areas for improvement and implement process enhancements to drive efficiency and productivity.
  • Technical Expertise: Possess a strong technical background, with a minimum of 5 years of experience in a related field, and proficiency in medical device protocol and validation.
  • Team Player: Demonstrate excellent communication and collaboration skills, with the ability to work effectively with various departments to achieve common goals.
  • Documentation and Reporting: Develop and maintain accurate and detailed documentation, including protocol and validation reports, manufacturing procedures, and drawings.
  • Manufacturing Experience: Possess experience working in a manufacturing environment, with a strong understanding of product and process development, design I/O validation, and mechanical principles.
  • Microsoft Suite Proficiency: Be proficient in using Microsoft Suite applications to support daily tasks and responsibilities.
  • Education and Experience: Hold a Bachelor's Degree in a technical field and possess a minimum of 5 years of related experience.


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