Role OverviewThe Quality and Regulatory Specialist manages assigned quality system processes and supports K-Tube's Quality Management System through customer complaints, corrective actions, regulatory and compliance requests, audits, return authorizations, calibration, and related quality activities.
What You Will Do
Reviews customer complaints and RA requests, coordinates investigations, corrective actions, and responses, tracks progress and commitments, and supports root cause investigations and continuous improvement activities.
Why It Might Be a Fit
The position requires a working knowledge of quality systems and quality principles, good communication skills, and the ability to thrive in a fast-paced environment, managing multiple projects and assignments simultaneously.
Requirements
- Associate degree in Quality, Engineering Technology, Manufacturing Technology, Industrial Technology, Science, or a related field
- Minimum 3 years experience in a Manufacturing or Quality environment
- Working knowledge of quality systems and quality principles
- General understanding of customer complaints, CAPA, root cause investigation, auditing, document control, calibration, and validation
- Approachable, inquisitive, and relates well to all kinds of people
- Good communication skills, both written and spoken
- Proficient with MS Word, Excel, Power Point, Outlook
Benefits
- Dental insurance
- Vision insurance
- Calibration
- Document control
- Auditing
- Validation
- Quality improvement projects
- Backup inspection support
- Working knowledge of inspection methods and quality requirements
- Physical requirements: ability to lift to 10 pounds
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