Quality Assurance Manager

5 days ago


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

We are a leading medical device manufacturer dedicated to delivering innovative solutions that improve patient outcomes. Our team is passionate about quality and committed to ensuring the highest standards in product development and manufacturing.

Job Summary

We are seeking an experienced Senior Quality Engineer to join our Product Development team. This role will be responsible for maintaining and improving our quality management system, supporting quality aspects of design and development, manufacture, and post-production of components and finished products.

The ideal candidate will have a strong background in quality engineering, regulatory compliance, and technical expertise in medical device manufacturing. They will be responsible for conducting Corrective and Preventive Action activities, leading teams focused on CAPA, and performing supplier audits and quality metric evaluations.

Key Responsibilities:
  • Maintain and improve our quality management system, including developing and revising quality procedures (SOPs and WIs), protocols, and testing methods.
  • Support quality aspects of design and development, manufacture, and post-production of components and finished products.
  • Conduct Corrective and Preventive Action activities, including investigating causes of non-conformance, determining root cause, and implementing corrective actions.
  • Lead teams focused on CAPA, risk assessment, and supplier quality programs.
  • Perform supplier audits, manage supplier metrics, and evaluate quality metrics.
  • Develop and maintain risk management files and quality control plans for components, devices, and processes.
  • Provide training and technical guidance to QA technicians and production staff.
Requirements:
  • Bachelor of Science degree in a technical area such as science, engineering, math, or equivalent experience.
  • A minimum of 7+ years of experience in a quality engineering role in regulated industry experience such as medical device or pharmaceutical.
  • Working knowledge of analog and digital circuits, embedded software and firmware, technical knowledge of hardware such as sensors, motors, valves.
  • Familiarity with electronics components, electrical PCB's, thermal systems, software testing and validations, unit and black box testing related to safety, performance, and compliance.
  • Strong unbiased advocate of compliance.
  • Expertise in FDA Quality System Regulation, ISO13485, MDD, ISO 9001, and ISO 14971, including experience auditing to these requirements.
  • Must possess technical writing, project management, and fundamental problem-solving skills.
  • Excellent writing and communication skills.
What We Offer:
  • An estimated salary of $120,000 - $150,000 per year.
  • A comprehensive benefits package, including health insurance, retirement plan, and paid time off.
  • Opportunities for professional growth and development in a dynamic and innovative company.
  • A collaborative and supportive work environment.


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