Complaints Engineer I

Manufacturing Quality Assurance work includes:
•Defining and specifying activities, processes, and standards to fulfill the quality requirements for a manufactured material, component, or product
•Building and maintaining the infrastructure and systems necessary to consistently ensure the timely delivery of quality products
•Auditing, monitoring, and determining the quality of manufacturing processes and/or outputs against defined internal and regulatory standards
•Reporting and troubleshooting manufacturing process deviations and defects in finished goods

 

Applies broad theoretical job knowledge typically obtained through advanced education. May require the following proficiency: • Work is closely supervised. • Problems faced are not typically difficult or complex. • Explains facts, policies and practices related to job area.

 

Position Overview:

Responsible for the investigation of customer complaints including, but not limited to, sample evaluations (when applicable), trend analysis, impact assessment, root/probable cause determination, complete investigations report and follow up of any pending actions related to complaints. All this process must be executed following applicable with Quality Systems regulations and standards like 21 CFR Part 820, ISO 13485, Japan MO-169, Brazil ANVISA, among others and plant procedures. This role works with all the business units of the Haina Site.

Key Responsibilities:

• Generate and analyze reports from the electronic complaint management system to identify and track reported issues.
• Conduct thorough investigations of assigned complaints within established timelines, including activities such as sample evaluations, documentation reviews, personnel interviews, and trend analyses.
• Collaborate with cross-functional teams to support complaint analysis and root cause investigations.
• Document investigation findings in accordance with approved procedures and ensure timely entry into the electronic quality system.
• Periodically compile and present complaint summaries, trends, and investigation outcomes to the multifunctional team to support risk assessment and decision-making.
• Communicate clearly and proactively regarding complaint trends, potential product risks, and investigation progress to drive continuous improvement.
• Prepare detailed reports and trend analyses related to complaints, and promptly notify the supervisor of any adverse events or critical findings requiring immediate action.
• Participate in cross-functional projects and initiatives related to product quality, process improvement, and regulatory compliance.
• Perform other duties as assigned by the supervisor, in alignment with departmental and organizational goals.

Skills & Experience:

• 1-2 years of experience in similar position in medical devices.
• Familiarity with regulatory standards, including 21 CFR 820, ISO 13485, EU MDR (Regulation 2017/745).
• Highly skilled in the Microsoft Office suite, with advanced expertise in Microsoft Excel for data analysis, reporting, and visualization.
• Familiarity with root cause analysis methodologies to support effective problem-solving in quality systems.
• Understanding of Corrective and Preventive Actions (CAPA) processes, including documentation, implementation, and effectiveness checks, in alignment with regulatory standards such as FDA 21 CFR Part 820 and ISO 13485.
• Proficient in authoring clear, accurate, and compliant documentation related to complaint investigations, including investigation reports, root cause analysis summaries, and CAPA records.
• Proven ability to work collaboratively within cross-functional teams while also demonstrating initiative and self-direction to work independently with minimal supervision when required.
• Solid communication skills with the ability to clearly present technical data and collaborate cross-functionally.

#LI-HG1 #Onsite

 

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About Convatec

Pioneering trusted medical solutions to improve the lives we touch:

Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With over 10,000 colleagues, we provide products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention, treatment for hard to heal wounds, at-risk skin and ulcerated tissue to supporting debilitating conditions, improved patient outcomes and reduced care costs. Convatec's revenues in 2025 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit: http://www.convatecgroup.com.