Supply Chain Quality Manager - Operations

• Own the quality program for Signant Health's 3PL partners and device/hardware suppliers — conducting audits, managing performance scorecards, driving CAPA processes to closure, and developing and maintaining quality agreements with 3PL vendors performing supply chain operations on Signant Health's behalf.
• Serve as the internal SME on transportation regulations for clinical devices containing lithium batteries and for medical devices — covering IATA DGR, IMDG, 49 CFR (DOT/PHMSA), and UN 38.3 test requirements; review and approve shipping configurations, packaging specifications, and dangerous goods documentation across the global warehouse network.
• Partner with 3PL vendors to ensure packaging meets DOT/IATA specifications, shipping documents are accurate, and all courier coordination is compliant; evaluate and close transportation compliance gaps across US, UK, and other warehouse locations as the supply chain footprint evolves.
• Define, implement, and maintain quality standards across the entire device lifecycle — procurement and receiving, asset tagging, device configuration, SIM activation, deployment to clinical sites, returns processing, redeployment qualification, country-specific regulatory certifications, and end-of-life disposal.
• Oversee quality controls for SIM card management including activation, project code assignment, multi-protocol branch selection, deactivation at study closeout, and removal from returned devices.
• Collaborate with MDM and configuration teams to ensure device enrollment, software deployment, and retirement meet quality and regulatory standards across Android, iOS, and Windows platforms; ensure medical device quality standards are maintained across sourcing and redeployment workflows.
• Maintain Signant Health's supply chain QMS in alignment with ISO 13485:2016 (incorporated into FDA QMSR / 21 CFR Part 820), EU MDR, and UK HSE requirements; monitor evolving regulations across consumer electronics (FCC, CE, WEEE/e-waste) and medical devices and proactively update internal policies, SOPs, and quality agreements.
• Ensure Good Documentation Practices are consistently applied across configuration records, picking slips, quality check logs, and deviation documentation; support internal audits, regulatory inspections, and customer quality reviews as the supply chain quality SME.
• Develop quality KPIs and dashboards covering supplier performance, transportation compliance, device lifecycle quality, and 3PL adherence; lead root cause analysis in collaboration with Supply Chain Operations.
• Lead continuous improvement initiatives across warehouse operations and 3PL partners; represent the quality function in cross-functional programs including new clinical study device launches, carrier integrations, warehouse model changes, and supply chain transformation initiatives.

• Bachelor's degree in Supply Chain Management, Engineering, Quality Management, Biomedical Engineering, or a related field; 6–9 years of progressive experience in supply chain quality, logistics compliance, or device operations, ideally within clinical trials, life sciences, telecom, or consumer electronics.
• Working knowledge of lithium battery transport regulations: IATA DGR, IMDG, 49 CFR/PHMSA, and UN 38.3.
• Solid understanding of ISO 13485:2016 / FDA QMSR (21 CFR Part 820) and EU MDR as they apply to supply chain and distribution operations.
• Experience designing and executing 3PL quality agreements, audits, and performance management programs.
• Familiarity with device lifecycle management in a clinical or enterprise context, from procurement through end-of-life.
• Proven ability to influence cross-functional stakeholders and drive quality outcomes without direct organizational authority.
• Experience with inventory management systems and Good Documentation Practices.
• Strong analytical skills with experience building KPI frameworks and quality reporting for leadership; experience applying structured problem-solving methodologies such as DMAIC, root cause analysis, or Lean Six Sigma.
• Experience leading cross-functional change initiatives and driving continuous improvement in regulated environments.
• Ability to utilize Company-issued and approved Artificial Intelligence (AI) tools to support productivity, efficiency, and quality of work, while maintaining accountability for all AI-generated outputs.

• ASQ Certified Quality Engineer (CQE) or Certified Manager of Quality/Organizational Excellence (CMQ/OE).
• ISO 13485 internal auditor certification.
• Lean Six Sigma Green Belt certification.
• IATA CEIV Lithium Battery certification or completion of the IATA Lithium Battery Logistics Safety Management course.
• APICS CPIM or CSCP.

Why Signant Health?

At Signant Health, your work has real impact.

Everything we build, support, and deliver helps advance clinical research and bring new treatments to patients faster — improving lives around the world.

Our teams combine science, technology, and operational expertise to solve complex clinical trial challenges, and every role contributes to that mission.

We offer a collaborative, global environment where you can grow your career while working alongside experts across clinical, technology, data, and operations, with opportunities to learn, take ownership, and drive meaningful innovation — not just maintain the status quo.

If you are looking for purpose-driven work, smart colleagues, and the opportunity to help shape the future of clinical research and digital health, Signant Health is the place to do it.

At Signant Health, accepting difference isn't enough — we celebrate it, we support it, and we nurture it for the benefit of our team members, our clients, and our community.

We are proud to be an equal opportunity workplace and an affirmative action employer, committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or veteran status.

Prior to their start date, all new hires are required to be verified through a thorough background check and identity verification to confirm eligibility for employment.

Unsolicited resumes submitted by agencies or third-party recruiters directly to hiring managers or any Signant Health employee will not be considered and will not obligate Signant Health to any fees or terms associated with the submission.