Quality Assistant

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.

Major Areas of Accountability

• 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
  
  

Authorities

• The Quality Assurance Assistant is authorized to perform quality-related tasks under the supervision of the Quality Manager, within the scope of:
• Coloplast’s policies and procedures.
• Training and competency requirements.
• Job-specific limitations as defined in local instructions or contracts.

Basic Qualifications

• 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 Qualifications

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

Competencies & Skills (training provided during onboarding)

• Ability to follow procedures and maintain accurate records.
• Strong attention to detail and ability to manage multiple tasks.
• Effective communication and collaboration with cross-functional teams.
• Willingness to learn and grow within the quality function.
• Highly motivated, detailed and results oriented with strong execution, organization, and administrative experience.
• Strong organizational and communication skills.

At Coloplast, we believe in recognizing and rewarding the contributions of our employees. Our total rewards package is designed to support your well-being, foster your professional growth, and ensure a healthy work-life balance. Here is some of what you can expect:

• Health and Wellness: Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus, access to company sponsored wellness programs and mental health resources, paid leave of absence for qualifying events and generous paid parental leave for both birthing and non-birthing parents.
• Financial Security: A competitive 401(k) plan with company match that vest immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.
• Work-Life Balance: Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.
• Professional Development: Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
• Recognition and Rewards: Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
• Community and Culture: 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.
• Competitive Compensation: The starting hourly rate for this position is $25.00. Hired candidates may be eligible to receive additional compensation for applicable experience and may also be eligible for bonuses and/or incentives.  Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16,000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Visit us on Coloplast.com.

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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.

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

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