Product Complaints Specialist - AID

Werfen•Bedford, MA

2d•$65,000 - $80,000•Onsite

About The Position

As a member of the Product Complaint Team, the Product Complaint Specialist receives and investigates product complaints via phone, email, or SAP. This role responds to customer complaints with a broad range of technical questions regarding assay performance and other assay-related concerns. The specialist is responsible for assessing customer issues and using judgment and technical expertise to carry out complaint investigation activities, including troubleshooting, investigations, product testing, and providing complaint resolution to customers within an FDA-regulated environment. Collaboration with internal teams and global affiliates may be required to respond to product inquiries and complaints. Strong interpersonal skills and technical product knowledge are critical for daily customer-centric activities. This position works under limited supervision to provide exceptional technical and customer service.

Requirements

Bachelor’s degree in biological science required.
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).
Working knowledge of quality systems regulations.
Working knowledge of Microsoft Office suite and ERP systems, preferably SAP required.
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.

Nice To Haves

1-2 years’ experience working in a regulated life sciences environment strongly preferred.
Medical device, IVD, autoimmunity related experience preferred.
Proven ability to multi-task, work under pressure, adapt and thrive in a fast-paced customer support/call center environment preferred.

Responsibilities

Receives, analyzes, and decides the best course of action to investigate customer complaints to determine root cause; follows up with customers in a professional, timely manner to close complaints.
Works proactively and professionally 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.
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.
Collaborates with department management to escalate potential product performance issues or quality systems issues using technical expertise and judgment. 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 and 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.