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Hello Heart · 1 day ago

Manager, Quality and Manufacturing

United States

Full-time

Remote

Mid, Senior Level

$140K/yr - $160K/yr

7+ years exp

Hello Heart is on a mission to change the way people care for their hearts, providing innovative solutions for heart health management. The Manager, Quality and Manufacturing will oversee quality engineering and manufacturing engineering functions for hardware products, ensuring production readiness and product quality throughout the manufacturing process.

FitnessHealth CareMedicalmHealthWellness

Responsibilities

Validate manufacturing readiness for NPI builds, including tools, fixtures, process flow, and documentation

Partner with engineering teams on DFM and DFA reviews, qualification testing, and readiness milestones

Create and maintain quality control plans across IQC, IPQC, and OQC processes

Define and implement manufacturing process controls, test requirements, and build validation plan

Lead structured root cause analysis using 8D, 5 Why, and Fishbone methodologies

Drive corrective and preventive actions and verify long-term effectiveness

Conduct line audits, capability studies (Cp and Cpk), and SPC monitoring to assess process health

Monitor yields, reduce defects, and drive continuous improvement across production lines

Assess supplier capability and lead onsite production reviews and factory evaluations

Define incoming inspection criteria, sampling plans, and supplier quality alignment

Maintain detailed build documentation, quality dashboards, and audit reports

Qualification

Quality engineeringManufacturing engineeringISO 9001ISO 13485Six SigmaRoot cause analysisSPCLean ManufacturingAnalytical skillsMandarin proficiencyCommunication skills