Product Complaints Specialist AID

Introduction

Werfen

Werfen is a growing family-owned innovative company founded in 1966 in Barcelona Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis Acute Care Diagnostics Transfusion Autoimmunity and Transplant. Through our Original Equipment Manufacturing (OEM) business line we research develop and manufacture customized assays and biomaterials. We operate directly in 30 countries and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe and our workforce is more than 7000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas our commitment to customers and our dedication to innovation and quality. Were passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Overview

Job Summary

As a member of the Product Complaint Team receives and investigates product complaints via phone email or SAP (Inovas ERP system). The Product Complaint Specialist 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. May collaborate 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 works under limited supervision to provide exceptional technical and customer service to customers.

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.
• Meets or exceeds department customer service and investigation standards.
• In collaboration with team participates in initial troubleshooting of customer calls as needed.
• Independently conducts investigations for routine product failures or customer requests for assistance.
• Conducts laboratory testing to support investigations and customer inquiries.
• Using technical expertise and judgement collaborates with department management to escalate potential product performance issues or quality systems issues. Escalates investigations with external departments and original equipment manufacturer (OEM) as needed.
• Ensures accurate documentation of the complaint evaluation MDR reportability risk assessment and investigation results in accordance with Inova SOPs and regulatory requirements.
• Reviews complaint investigations for accuracy and completeness.
• Maintains records in SAP performs laboratory activities in accordance with SOPs and good documentation practices (GDP).
• Generates reports as required to document complaint investigations and or projects.
• Performs specialized tasks under the direction of department management in accordance with standard operating procedures.
• Works on assigned projects and provides observations recommendations and reports to management.
• Monitors and maintains laboratory supplies and equipment with approval of department management.
• 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

• Customer service and interpersonal skills
• Analytical skills
• Problem solving judgement and decision making skills
• Strong written and verbal communication
• Good laboratory skills
• Solid understanding of Medical Device Reportability and Quality System Regulations

Qualifications

Minimum Education Experience Skills and Knowledge

Education:

• Bachelors degree in biological science required

Experience:

• 1-3 years of experience with diagnostic reagents or instruments required.
• 1-2 years of customer facing experience required (call center or other direct customer contact).
• 1-2 years; experience working in a regulated life sciences environment strongly preferred.
• Medical device IVD autoimmunity related experience preferred.

Skills & Knowledge:

• Working knowledge of quality systems regulations.
• Working knowledge of Microsoft Office suite and ERP systems preferably SAP required.
• Proven ability to multi-task work under pressure adapt and thrive in a fast-paced customer support/call center environment 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

Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job the employee is regularly required to communicate. Must be able to detect identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day. Must be able to use hands to feel objectives including keyboard telephone and pipettes or other lab equipment. May need to reach with hands and arms climb stairs balance stoop kneel or crouch. Will be required to talk and hear and have specific vision abilities including close vision distance vision color vision peripheral vision depth perception and ability to adjust focus. May occasionally have to lift and/or move up to 25 pounds. The noise level in the work environment will vary but is usually moderate.

Travel requirements

• Less than 5%

The annual base salary range for this role is currently $65000.00 to $80000.00. Individual employee compensation will ultimately depend on factors including education relevant experience skillset knowledge and particular business needs.

This role is eligible for medical dental and vision insurance 401k plan retirement benefits with an employer match as well as paid vacation and sick sales roles are eligible for participation in a commission plan and our managementand select professional rolesare eligible for a performance-based bonus.

Closing

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination harassment or retaliation based upon an individuals race color religion gender sexual orientation gender identity/expression national origin/ancestry age mental/physical disability medical condition marital status veteran status or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process please contact for assistance.

We operate directly in over 30 countries and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7000 employees around the world comprise our Werfen team.

Required Experience:

IC