Job Description

About SQ Innovation, Inc.

SQ Innovation is a privately held Swiss biopharmaceutical company located in Zug, Switzerland, and Burlington, MA. The company was established to develop and commercialize innovative cost-effective therapies for subcutaneous delivery of pharmaceutical products where and when needed. Its first product was designed specifically for the treatment of fluid overload due to worsening heart failure. The innovative combination product is based on a novel high-concentration formulation and uses a cost-effective two-component device design. The device was designed with the patient, provider, payor, and environment in mind to enable home treatment as an alternative to hospital admission for selected patients. The Infusor uses a reusable motorized component and a disposable component. The company's products are subject to regulatory review and approval. For further information visit and for Important Safety Information and Prescribing information for Lasix ® ONYU visit

Position Summary

We are seeking a highly organized and detail-oriented Complaint Manager to plan, develop, and execute our complaint management process for our innovative drug/device combination product. This role is critical to ensuring timely, compliant, and efficient handling of product complaints and returns. The Complaint Manager will have operational responsibility for intake, inspection initiation, decontamination, tracking, coordination with Quality Engineering and 3 rd party vendor, disposition of returned products, reporting and maintaining complete chain-of-custody for documentation and returned products.

Job Requirements

• Complaint and Return Intake
• Provide prompt and helpful assistance to internal & external customers inquiring about replacement products, status of returns, and cost options
• Receive, log, and triage incoming customer complaints and returned products both physically and digitally
• Maintain accurate and up-to-date complaint and return records in tracking systems
• Follow up with customers to ensure that products are returned
• Process Development, Execution and Workflow Initiation
• Support the selection, implementation, and ongoing management of the QMS, ensuring alignment with complaint handling and returned product workflows
• Serve as the subject matter expert (SME) for the Quality Management System (QMS), including system configuration, user support, and process integration.
• Develop and execute process in adherence to SOP’s
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Initiate product inspection and disposition workflows for all returned products
• Coordination with Quality Engineering
• Collaborate closely with Engineering and other subject matter experts to investigate, resolve, and close complaints
• Facilitate timely inspections, root cause analyses, and corrective actions for returned products flagged by QE
• Chain-of-Custody Management
• Ensure timely closure of complaints (cycle time) and maintain complete complaint documentation files
• Ensure that all returned products maintain strict chain-of-custody documentation from receipt through final disposition
• Safeguard product integrity during intake, storage, and processing stages
• Provide oversight into work done offsite and by 3rd party vendors to ensure adherence to standards
• Reports & Audits
• Maintain the complaint handling process in compliance with global regulatory requirements
• Act as an effective and collaborative leader or team member in supporting quality disciplines, decisions, and practices
• Support audits and regulatory inspections related to complaint handling
• Maintain and manage the complaint-related risk register, including identification, assessment, and documentation of risks associated with returned products and customer complaints
• Assist with KPI/trend analysis
• Continuous Improvement
• Collaborate with cross-functional teams to determine root causes and drive corrective and preventive actions (CAPAs)
• Work closely with cross-functional teams to collect CSAT/feedback post-replacement and identify areas for product improvements
• Contribute to PMS reports to ensure continuous improvement and regulatory compliance

Qualifications

• Bachelor’s degree in a related field (e.g., Quality Assurance, Life Sciences, Business Administration) or equivalent experience.
• 3+ years of experience in complaint management, quality assurance, or related operations, preferably in a regulated industry (e.g., medical device, pharmaceuticals, consumer products)
• Strong knowledge of complaint handling processes, regulatory requirements, and industry best practices
• Exceptional organizational skills with the ability to manage multiple tasks and priorities simultaneously
• Proficiency with complaint tracking systems, CRM, ERP, or other relevant databases
• Excellent written and verbal communication skills
• High attention to detail and a commitment to maintaining compliance and product integrity
• High sense of urgency and commitment to execution

Preferred Qualifications

• Experience with chain-of-custody protocols and documentation.
• Experience developing and implementing complaint handling and PMS processes within quality management systems.
• Working knowledge of ISO standards (e.g., ISO 13485) or FDA complaint handling regulations (21 CFR Part 820).
• Certification in Quality Management (e.g., CQE, CQA) is a plus.

Work Location: This is a full-time, on-site position. Due to the nature of the job responsibilities, remote or hybrid work arrangements are not available.

SQ Innovation, Inc. does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state, or local law.

Due to the nature of SQ Innovation’s work within the Supply Chain as well as for the safety of our employees, consultants, clients, and vendors, SQ Innovation follows the guidance of the Federal Center for Disease Control (CDC). As such, SQ Innovation continues to encourage vaccinations, masks (when appropriate or advised), testing, and other preventative non-emergency measures to limit the risk of transmitting communicable diseases. 

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