Date: 12 Feb 2025
Location: Kulim, 02, MY
Company: Teleflex
Expected Travel: None
Requisition ID: 11783

POSITION SUMMARY

Individual contributor assisting the Team Lead (Complaint Investigation Lab) and manufacturing sites with all matters related to complaint sample processing and complaint investigations, performed in the Kulim complaint investigation laboratory.

EDUCATION / EXPERIENCE REQUIREMENTS

• B.S. Degree or equivalent work experience.
• 1+ years of (medical device preferred) experience.

SPECIALIZED SKILLS / OTHER REQUIREMENTS

• Excellent use of grammar and writing skills.
• Ability to multi-task.
• Experience utilizing ERP system like SAP
• Experience utilizing complaint management system.
• Displays a positive attitude as a Customer Advocate for Teleflex, Inc.
• Participates in departmental initiatives/objectives outside the scope of daily responsibilities.
• Supports regulatory inspections, ISO audits, or corporate audits.
• Consistently performs at a high level for the department.

PRINCIPAL RESPONSIBILITIES

• Executes complaint investigations and other laboratory functions performed in the Kulim complaint laboratory to ensure quality and timeliness for Regulatory reporting.
• Executes complaint sample processing to maximize efficiencies and integrity of complaint samples.
• Supports complaint sample through-put and complaint investigation timeliness and documents associated processes.
• Supports the Team Lead in relation to interfacing with a variety of internal and external customers including: Global Operations, Manufacturing, Marketing, Research & Development, and Regulatory.
• Supports during regulatory inspections and/or audits as required.
• Utilize SAP, Agile and other systems as warranted for data input and quality record maintenance.
• Utilize sound technical writing to provide clear and concise written internal reports and support external communications as needed to product quality issues.
• Documents laboratory and complaint investigation processes according to established guidelines.
• Notifies manufacturing site(s) of any potential manufacturing issue as a result of a reported complaint.
• Coordinates investigations requiring more in-depth testing with Research & Development.
• Perform other duties as assigned or necessitated by business conditions or changes.
• Adheres to local site (Kulim) protocols and Standard Operating Procedures and global Quality Management System (QMS) requirements.