Werfen North America
Product Complaints Specialist III - AID
Werfen North America, San Diego, California, United States, 92189
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Product Complaints Specialist III - AID
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Werfen North America . Position Summary: As a senior member of the Product Complaint Team, you will receive and investigate product complaints via phone, email, or SAP (Inovas ERP system). You will respond to customer complaints on a broad range of technical questions regarding assay performance and other assay-related concerns. Your responsibilities include assessing customer issues, troubleshooting, investigations, product testing, and providing complaint resolution within an FDA-regulated environment. Collaboration with internal teams and global affiliates is essential. Interpersonal skills, technical product knowledge, and expertise are critical for daily customer-centric activities. This role also provides subject matter expertise in technical and customer relationship management to junior team members. Responsibilities include: Analyzing and investigating customer complaints to determine root cause and following up professionally. Working proactively with customers to resolve complaints, provide information, and exceed expectations. Maintaining an advanced understanding of Inovas systems and product use in clinical settings. Understanding product failure modes and risk management. Leading initial troubleshooting and guiding junior team members. Conducting complex investigations and laboratory testing to support inquiries. Escalating potential product performance or quality issues. Participating in product failure resolution projects. Ensuring documentation complies with SOPs and regulatory requirements. Generating reports and performing trend analysis. Leading specialized tasks and projects, including product improvements. Developing and executing training for staff. Complying with SOPs, ISO 13485, FDA 21 CFR, and other regulations. Qualifications include: Bachelors degree in biological sciences (Masters preferred). 5+ years of experience with diagnostic reagents/instruments, complaint handling, and working in regulated environments. Strong knowledge of quality systems, Microsoft Office, ERP systems (preferably SAP), and experience training junior staff. Other details: International mobility required: yes/no. Work environment involves typical laboratory and office activities, with physical demands including standing, walking, and lifting up to 25 pounds. Travel less than 5%. Salary range: $80K-$110K. Employment type: Full-time, Mid-Senior level, in the Medical Equipment Manufacturing industry. #J-18808-Ljbffr
Product Complaints Specialist III - AID
role at
Werfen North America . Position Summary: As a senior member of the Product Complaint Team, you will receive and investigate product complaints via phone, email, or SAP (Inovas ERP system). You will respond to customer complaints on a broad range of technical questions regarding assay performance and other assay-related concerns. Your responsibilities include assessing customer issues, troubleshooting, investigations, product testing, and providing complaint resolution within an FDA-regulated environment. Collaboration with internal teams and global affiliates is essential. Interpersonal skills, technical product knowledge, and expertise are critical for daily customer-centric activities. This role also provides subject matter expertise in technical and customer relationship management to junior team members. Responsibilities include: Analyzing and investigating customer complaints to determine root cause and following up professionally. Working proactively with customers to resolve complaints, provide information, and exceed expectations. Maintaining an advanced understanding of Inovas systems and product use in clinical settings. Understanding product failure modes and risk management. Leading initial troubleshooting and guiding junior team members. Conducting complex investigations and laboratory testing to support inquiries. Escalating potential product performance or quality issues. Participating in product failure resolution projects. Ensuring documentation complies with SOPs and regulatory requirements. Generating reports and performing trend analysis. Leading specialized tasks and projects, including product improvements. Developing and executing training for staff. Complying with SOPs, ISO 13485, FDA 21 CFR, and other regulations. Qualifications include: Bachelors degree in biological sciences (Masters preferred). 5+ years of experience with diagnostic reagents/instruments, complaint handling, and working in regulated environments. Strong knowledge of quality systems, Microsoft Office, ERP systems (preferably SAP), and experience training junior staff. Other details: International mobility required: yes/no. Work environment involves typical laboratory and office activities, with physical demands including standing, walking, and lifting up to 25 pounds. Travel less than 5%. Salary range: $80K-$110K. Employment type: Full-time, Mid-Senior level, in the Medical Equipment Manufacturing industry. #J-18808-Ljbffr