Product Complaints Specialist III - AID

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 7,000 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. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

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.

• 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.

• No budgetary responsibility

• 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

• 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

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.

• 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.

• Less than 5%

$80K-$110K

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 individual's 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 NAtalentacquisition@werfen.com 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 7,000 employees around the world comprise our Werfen team.

www.werfen.com