POSITION SUMMARY

As a senior member of the Product Complaint Team receives and investigates product complaints via phone, email or SAP (Inova’s ERP system). Responds to customer complaints on a broad range of technical questions regarding assay performance and other assay related concerns. Responsible for assessing customer issues and using judgement and technical expertise to carry out a variety of complaint investigation-related activities, including troubleshooting, investigations, product testing and providing complaint resolution to customers within an FDA regulated environment. Collaborates with other internal teams and global affiliates to respond to product inquiries and complaints. Interpersonal skills and technical product knowledge and expertise are critical to responding to daily customer-centric activities. This position provides subject matter expertise in technical and customer relationship management to junior members of the team.

QUALIFICATIONS

Minimum Education, Experience, Skills and Knowledge

EDUCATION:

• Bachelor’s degree in biological science required, Master’s degree preferred.

EXPERIENCE:

• 5+ years of experience with diagnostic reagents and instruments required.
• 5+ years of technical or complaint related experience in a call center environment required.
• 5+ years of experience working in a regulated life sciences environment required.
• Medical device, IVD, autoimmunity related experience strongly preferred.

SKILLS & KNOWLEDGE:

• Thorough understanding of quality systems regulations.
• Advanced Microsoft Office suite and ERP systems knowledge, preferably SAP required.
• Proven ability to multi-task, work under pressure, adapt and thrive in a fast-paced customer support/call center environment strongly preferred.
• Experience training or providing guidance and direction to junior team members strongly preferred.

MANAGEMENT HAS THE DISCRETION OF SUBSTITUTING RELEVANT WORK EXPERIENCE FOR A DEGREE AND/OR MAKING EXCEPTIONS TO THE YEARS OF EXPERIENCE REQUIREMENT.

International Mobility

• Required: yes or no

Key Accountabilities

• Receives, analyzes, and decides best course of action to investigate customer complaints to determine root cause; follows up with customers in a professional, timely manner to close complaints.
• Responsible for proactively and professionally working with customers to resolve complaints, provide information and education where appropriate, and meet or exceed customer expectations. Provides customer-focused resolution communication directly to customers, affiliates and team members.
• Possesses an advanced understanding of Inova’s systems (both reagents and equipment), including an advanced level understanding of autoimmune disease diagnosis and Inova product use in the clinical setting.
• Responsible for maintaining a deep understanding of Inova product failure modes and risk management.
• Meets or exceeds department customer service and investigation standards.
• In collaboration with team, leads initial troubleshooting review of customer calls as needed. Provides guidance to junior members of the team.
• Independently conducts complex investigations for product failures or customer requests for assistance; includes conducting advanced and escalated complaint investigations.
• Conducts laboratory testing to support investigations and customer inquiries.
• Using technical expertise and judgement, escalates potential product performance issues or quality systems issues.
• Participates in complex product failure resolution projects with other departments and original equipment manufacturer (OEM) to troubleshoot and resolve escalated failures.
• Ensures accurate documentation of the complaint evaluation, MDR reportability, risk assessment and investigation results, in accordance with Inova SOPs and regulatory requirements.
• Generates reports, as required, to document complaint investigations and or projects, including performing complaint trend analysis.
• Responsible for leading specialized tasks and projects, including product improvement projects to provide the customer perspective.
• In consultation with department management, develops and executes training for new and developing staff.
• Performs other duties and projects as assigned to meet company and department objectives.
• Complies with applicable Inova standard operating procedures (SOPs), ISO 13485, FDA 21 CFR and other applicable Quality System regulations, as well as applicable Environmental Health & Safety, Human Resources and other regulatory and administrative policies.
• Reflects the values of Werfen and Inova in the quality of work and in working relationships

RESPONSIBILITIES

Key Accountabilities

• Receives, analyzes, and decides best course of action to investigate customer complaints to determine root cause; follows up with customers in a professional, timely manner to close complaints.
• Responsible for proactively and professionally working with customers to resolve complaints, provide information and education where appropriate, and meet or exceed customer expectations. Provides customer-focused resolution communication directly to customers, affiliates and team members.
• Possesses an advanced understanding of Inova’s systems (both reagents and equipment), including an advanced level understanding of autoimmune disease diagnosis and Inova product use in the clinical setting.
• Responsible for maintaining a deep understanding of Inova product failure modes and risk management.
• Meets or exceeds department customer service and investigation standards.
• In collaboration with team, leads initial troubleshooting review of customer calls as needed. Provides guidance to junior members of the team.
• Independently conducts complex investigations for product failures or customer requests for assistance; includes conducting advanced and escalated complaint investigations.
• Conducts laboratory testing to support investigations and customer inquiries.
• Using technical expertise and judgement, escalates potential product performance issues or quality systems issues.
• Participates in complex product failure resolution projects with other departments and original equipment manufacturer (OEM) to troubleshoot and resolve escalated failures.
• Ensures accurate documentation of the complaint evaluation, MDR reportability, risk assessment and investigation results, in accordance with Inova SOPs and regulatory requirements.
• Generates reports, as required, to document complaint investigations and or projects, including performing complaint trend analysis.
• Responsible for leading specialized tasks and projects, including product improvement projects to provide the customer perspective.
• In consultation with department management, develops and executes training for new and developing staff.
• Performs other duties and projects as assigned to meet company and department objectives.
• Complies with applicable Inova standard operating procedures (SOPs), ISO 13485, FDA 21 CFR and other applicable Quality System regulations, as well as applicable Environmental Health & Safety, Human Resources and other regulatory and administrative policies.
• Reflects the values of Werfen and Inova in the quality of work and in working relationships.

REASONABLE ACCOMMODATIONS MAY BE MADE TO ENABLE INDIVIDUALS WITH DISABILITIES TO PERFORM THESE ESSENTIAL FUNCTIONS.

Budget Managed

• No budgetary responsibility

Internal Networking/Key Relationships

• Technical Support team
• Sales team
• Field Services team
• Global Systems Support team
• Manufacturing teams
• Regulatory Affairs team
• R&D team, including MTS team
• Marketing team
• Werfen international Affiliates

Competencies

• Exceptional customer service and interpersonal skills
• Strong Analytical skills
• Expert Problem solving, judgement and decision making skills
• Exceptional written and verbal communication
• Strong laboratory skills
• Deep understanding of Medical Device Reportability and Quality System Regulations