Senior Quality Engineer

3 weeks ago


Allen, Texas, United States Quest Medical, Inc. Full time
About the Role

We are looking for a Senior Quality Engineer to join our team at Quest Medical, Inc. This is a full-time position that will be responsible for maintaining and improving the quality management system.

Estimated Salary: $130,000 - $190,000 per year

The successful candidate will have a minimum of 5 years of experience in a quality engineering role in a regulated industry such as medical device or pharmaceutical.

The ideal candidate will have a strong understanding of FDA Quality System Regulation, ISO13485, MDD, ISO 9001, and ISO 14971. Experience with auditing to these requirements and all facets of IEC 60601 is essential.

Key Responsibilities:
  • Maintaining and improving the quality management system
  • Conducting Corrective and Preventive Action activities to investigate causes of non-conformance
  • Leading teams focused on CAPA
  • Supporting supplier quality program by performing audits and managing supplier metrics
  • Developing various product tests and conducting data analysis
Requirements:
  • Bachelor of Science degree in a technical area such as science, engineering, math or equivalent experience
  • A minimum of 5 years of experience in a quality engineering role in a regulated industry
  • Working knowledge of analog and digital circuits, embedded software and firmware, technical knowledge of hardware such as sensors, motors, valves
  • Familiarity of electronics components, electrical PCB's, thermal systems, software testing and validations


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