Quality Assistant Jobs

Coloplast

Location:
United States, Brookshire

Category:
Quality Control

Contract Type:
Not provided

Salary:

25.00 USD / Hour

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Job Description:

The Quality Assurance Assistant supports the Quality Manager in maintaining and improving the Quality Management System (QMS) at the Houston Distribution Center. This role assists with document control, audit preparation, non-conformance tracking, and quality data analysis. The assistant plays a key role in ensuring compliance with internal procedures and external regulatory requirements (e.g., FDA, ISO 9001/13485), while contributing to continuous improvement initiatives.

Job Responsibility:

Maintain and manage document control systems, including archiving and retrieval for production value streams
Support resolution of non-conformities related to documentation and quality records
Promote and train employees in Good Documentation Practices (GDP) across production and non-production teams
Develop and manage stability study protocols and reports
serve as liaison with global QA functions
Participate in and facilitate Root Cause Analysis (RCA) sessions for quality events
Prepare and distribute Certificates of Compliance/Analysis for finished goods
Support internal and external audits by preparing documentation and participating in audit activities
Analyze and maintain QA processes and procedures to ensure compliance, effectiveness, and continuous improvement
Review and maintain cleaning logs to ensure compliance with hygiene standards
Monitor pest control records and escalate any issues to the appropriate personnel
Track and document temperature monitoring logs for storage and operational areas
Support the review and processing of kitting work orders to ensure accuracy and completeness
Perform tasks in compliance with Coloplast’s quality and safety policies
Escalate issues or inefficiencies in quality processes to the Quality Manager
Maintain confidentiality and integrity of quality records and data
Support the positive EHS culture and contribute to a safe working environment
Coloplast employees are required to conduct business to the highest ethical and professional standards
comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies
Other job duties as assigned

Requirements:

Technical training or coursework in Quality, Logistics, or related field
1–2 years of experience in a regulated manufacturing or distribution environment
Proficiency in Microsoft Office 365 (Word, Excel, PowerPoint)
Language: Fluent in English

Nice to have:

Familiarity with FDA regulations and ISO 9001/13485 standards
Experience with document control systems and audit support

What we offer:

Comprehensive medical, dental, and vision insurance plans
Access to company sponsored wellness programs and mental health resources
Paid leave of absence for qualifying events
Generous paid parental leave for both birthing and non-birthing parents
Competitive 401(k) plan with company match that vest immediately
Financial planning services
Corporate discount programs for goods and services
Generous paid time off
Flexible work hours
Flexible work arrangement options
Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement
Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events
A supportive work environment
Participate in team-building activities, volunteer opportunities, and company-sponsored events

Additional Information:

Job Posted:
December 07, 2025

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Quality Assistant