Quality System Auditor jobs in United States
cer-icon
Apply on Employer Site
company-logo

Kimball Electronics · 4 days ago

Quality System Auditor

Kimball Electronics is seeking a Quality System Auditor who is passionate about regulatory compliance and continual improvement. This role involves leading internal audits, identifying compliance risks, and ensuring the highest standards of quality in the medical device manufacturing plant.

ElectronicsManufacturing
badNo H1Bnote

Responsibilities

Lead internal audits and recommend corrective actions
Identify compliance risks within processes by scheduling, preparing, and executing internal audits
Communicate findings and make improvement recommendations within the organization
Champion continuous improvement initiatives for the Quality Management System (QMS)
Educate other departments on regulatory requirements and share best practices

Qualification

Quality management systemsFDA regulationsISO 13485 standardsInternal auditsData analysisCertified Internal AuditorCertified Quality AuditorCommunication skillsProblem-solvingAttention to detail

Required

Bachelor's degree or equivalent experience
Minimum of two years experience in quality management systems, particularly in medical device manufacturing
Working knowledge of FDA regulations (21 CFR Part 820) and ISO 13485 standards
Experience in conducting internal audits
Ability to analyze data and implement corrective actions
Strong verbal and written communication skills across all levels of the company
Effective problem-solving and decision-making abilities
High level of accuracy and attention to detail

Preferred

Completion of certified Internal Auditor or Lead Auditor training course can be beneficial
Certifications such as Certified Quality Auditor (CQA) can be beneficial

Company

Kimball Electronics

twittertwittertwitter
company-logo
Kimball Electronics is an electronics manufacturer.