Quality Compliance Specialist - Oral Care
On-site · Grand Rapids, Michigan, United States
Job Summary
Quality Compliance Specialist for oral-care products focused on regulatory compliance across medical devices, pharmaceutical, and cosmetic products. Responsibilities include acting as a liaison for the insourced complaint handling system, reviewing complaint reports, supporting Medical Device Reporting (MDR) evaluations, CAPA administrative activities, participating in internal/external audits and inspections, serving as scribe during external audits, assisting with internal GMP audits, escalating issues to management, supporting QMS documentation and meetings, following GMP requirements, and performing basic data analysis in Excel. Requires collaboration with multiple functional groups, learning Perrigo products, and identifying high-risk or rising trend issues for escalation.
Required Qualifications
- Bachelor’s degree in technical disciplines such as Engineering, or Science preferred
- Minimum of 1+ years of experience in medical device industry or pharmaceutical environment
- Proficient in the English language
- Proficient in Microsoft Office and TrackWise
- Good verbal and written communication skills
- Ability to perform basic data analysis, charting and graphing in Excel
- Self-motivated, with excellent attention to detail
- Read, understand, and interpret manuals and written instructions
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