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Quality Assistant

coloplast.com Logo

Coloplast

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Location:
United States , Brookshire

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Category:
Quality Control

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Contract Type:
Not provided

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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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