Coloplast · 1 month ago
Quality Assistant
Brookshire, TX
Full-time
Hybrid
Entry Level
$25/hr - $25/hr
1+ years expColoplast is a leading medical device company that develops and markets products for intimate healthcare needs. The Quality Assurance Assistant supports the Quality Manager in maintaining and improving the Quality Management System at the Houston Distribution Center, ensuring compliance with regulatory requirements and contributing to continuous improvement initiatives.
Health CareManufacturingMedical Device
Responsibilities
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
Other job duties as assigned
Qualification
Required
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
Preferred
Familiarity with FDA regulations and ISO 9001/13485 standards
Experience with document control systems and audit support
Benefits
Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy.
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.
A competitive 401(k) plan with company match that vest immediately.
Financial planning services to help you secure your future.
Corporate discount programs for goods and services.
Generous paid time off.
Flexible work hours.
Flexible work arrangement options to help you balance your personal and professional life may be available.
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 where everyone feels valued, and has a sense of belonging.
Participate in team-building activities, volunteer opportunities, and company-sponsored events.
Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.
Company
Coloplast
Coloplast is a manufacturer of medical devices that offers ostomy, continence, and wound care products.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$1.34B2023-08-29Post Ipo Equity· $1.34B
2000-02-04IPO
Leadership Team
Lars Rasmussen
Chairman of the Board of Directors
Recent News
Essential Business
2025-12-20
2025-12-18
2025-12-05
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