Quality Compliance Specialist - Oral Care
Perrigo•Kentwood, MI
About The Position
The Quality Compliance Specialist is responsible for ensuring compliance with regulatory requirements and internal quality standards while supporting post-market surveillance activities. This role focuses on reviewing and analyzing product complaints to monitor product safety and performance across medical devices, pharmaceutical, and cosmetic products.
Requirements
- 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.
- Work well with peers and management in a team environment and as an individual contributor.
- Good verbal and written communication skills.
- Proficient in Microsoft Office and TrackWise.
- Ability to perform basic data analysis, charting and graphing in Excel.
- Understand and carry out oral instructions.
- Read, understand, and interpret manuals and written instructions.
- Self-motivated, with excellent attention to detail.
Responsibilities
- Act as a Liaison for the insourced Complaint Handling system.
- Review complaint reports from various sources for different products.
- Support Medical Device Reporting (MDR) evaluations.
- Support CAPA administrative activities.
- Participate in internal and external audits/inspections, including preparation and on-site support.
- Serve as scribe during external audits.
- Assist with coordination of internal audits and GMP floor audits.
- Escalate issues to Senior Compliance Specialist or Management.
- Support administrative tasks for QMS meetings and documentation.
- Follow GMP requirements.
- Support continuous improvement initiatives to enhance product quality and compliance.
- Perform basic data analysis, including statistical trending using Excel charts/graphs.
- Learn Perrigo products, becoming knowledgeable on product failure modes and performance issues.
- Identify unique situations, high-risk complaints, or increasing trends and escalate to management.
- Work and communicate with a variety of different functional groups.
- Support effective implementation of all GMP requirements and understand how it affects products/processes supported and/or owned.
Benefits
- Competitive compensation
- Benefits tailored to supporting you and your family
- Career development opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
