Product Complaints Specialist - AID

Job Type: Temporary Location: Werfen - Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States Overview As a member of the Product Complaint Team, receives and investigates product complaints via phone, email or SAP (Inova's 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 judgment 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 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 judgment, collaborates with department management to elevate 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. Qualifications Education: Bachelor's 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. 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% Compensation and Benefits The annual base salary range for this role is currently $65,000.00 to $80,000.00. 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 leave. The sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance‑based bonus. Equal Opportunity Employer 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 View email address on click.appcast.io for assistance. #J-18808-Ljbffr Werfen