Quality Systems Specialist

1 month ago


Logan, Utah, United States ELITechGroup Inc. Full time
Job Title: Quality Systems Specialist

Join ELITechGroup Inc. as a Quality Systems Specialist and play a vital role in ensuring the highest standards of quality in our organization.

Job Summary

We are seeking a highly skilled and experienced Quality Systems Specialist to support the creation, development, management, maintenance, control, and overall improvement of our Quality Management System and corresponding processes, procedures, work instructions, and records.

Key Responsibilities
  • Quality Planning: Develop and execute quality plans to ensure the highest standards of quality in our organization.
  • Quality Management System Support: Provide support to the Quality Management System team in implementing and maintaining the system.
  • Corrective and Preventive Action (CAPA): Investigate and resolve quality-related issues through the CAPA process.
  • Nonconforming Product: Identify, track, control, and quarantine nonconforming products to prevent reoccurrence.
  • Complaint Handling: Investigate and resolve customer complaints in a timely and effective manner.
  • Internal Audits / External Audits: Conduct internal audits and participate in external audits to ensure compliance with regulatory requirements.
  • Quality Training: Provide quality training to employees to ensure they understand and adhere to quality procedures.
  • Process Control and Quality Improvement: Identify opportunities for improvement and implement changes to reduce variation and improve overall quality.
  • Document Control and Record Control: Maintain accurate and up-to-date records of all actions and decisions.
Qualifications
  • Bachelor's degree in Life Science or Engineering discipline plus three years quality-related experience in the manufacturing industry.
  • Practical experience in quality planning, Corrective/Preventive Actions systems, quality auditing, root cause analysis, and problem-solving.
  • Good knowledge and skills in the use of advanced personal computer productivity programs.
  • Demonstrates working knowledge of ISO13485 quality system and/or FDA 21 CFR 820 quality.
Work Environment

This role requires a high level of confidentiality and the ability to work effectively with all levels of the organization, management, and staff.



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