Quality Assurance Specialist

1 week ago

Allen, Texas, United States Quest Medical, Inc. Full time
Job Summary

Quest Medical, Inc. is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our Quality Operations department, you will be responsible for ensuring the highest level of quality in our products and processes.

Key Responsibilities
  • Process Review and Compliance: Conduct regular reviews of our processes to ensure procedural compliance and recommend improvements to maintain our high standards.
  • Internal and External Audits: Provide support during internal, customer, and regulatory audits to ensure our quality systems meet the required standards.
  • Inspection and Verification: Perform inspections and verification of finished products, including line clearance and in-process inspections, to ensure they meet our quality requirements.
  • Documentation and Review: Review inspection data and documentation, including sterilization records, for accuracy and compliance to applicable standards.
  • Returned Goods and Materials: Inspect and process returned goods and materials, including evaluating materials for extended expiration dates.
  • Sampling and Testing: Use recognized sampling plans to determine statistical sample sizes and perform tests according to various protocol requirements.
  • Training and Development: Provide training and coordinate training for new technicians to ensure they have the necessary skills and knowledge to perform their duties.
  • Non-Conforming Material Reports: Generate non-conforming material reports for products that do not meet test specifications and communicate with the appropriate personnel.
  • Communication and Coordination: Communicate the needs of the department and company to management and coordinate the needs of internal customers with technicians in your area of responsibility.
  • Process Improvement: Assist engineering staff with process improvement projects related to improved quality inspection of products and components.
  • Supplier Certification: Evaluate certification status of raw materials under the Supplier Certification program.
  • Adaptability and Flexibility: Be able to work in various Quality Operation areas, including Cleanroom In-Process QC and Finals QC, and adapt to changing environments and priorities.
Requirements
  • Education: High School graduate or equivalent work-related experience with some previous quality control experience desired (minimum of 5 years).
  • Inspection Skills: Strong inspection ability using a caliper, micrometer, vision system, and other inspection and measurement tools.
  • Computer Skills: Detail-oriented, computer literate, and possess a professional demeanor, with basic knowledge of MS Office.
  • Communication Skills: Good written and oral communication skills, with the ability to read, write, and understand English, and interpersonal skills dealing with other departments and individuals in a team atmosphere.
  • Medical Device Experience: Medical device experience desired.

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