Quality Compliance Specialist - Oral Care

Trusted Consumer Self-Care Products • Grand Rapids, MI

3d

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level