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Hello Heart

Empowering people to understand and improve their heart health using technology and behavioral science.

Manager, Quality – Manufacturing

ManagerManagerFull TimeRemoteLeadTeam 51-200Since 2013H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

89 days ago

Salary

$140K - $160K / year

Seniority

Lead

Bachelor Degree7 yrs expEnglish

Job Description

• 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

Job Requirements

  • 7+ years of experience in quality engineering, manufacturing engineering, or a related hardware-focused discipline
  • Hands-on experience with production lines, fixtures, test equipment, and hardware manufacturing processes
  • Strong understanding of quality systems including ISO 9001, ISO 13485, PFMEA, SPC, and Six Sigma
  • Proven experience leading root cause analysis and driving corrective actions
  • Experience working with contract manufacturers and suppliers, preferably in Asia
  • Strong analytical skills with the ability to interpret yield trends, SPC data, capability studies, and defect data
  • Experience supporting NPI builds and high-volume product ramp is preferred
  • Familiarity with reliability testing and environmental qualification is preferred
  • Knowledge of hardware system integration spanning mechanical and electrical components is preferred
  • Experience with DOE, process optimization, or Lean Manufacturing is preferred
  • Mandarin language proficiency is a plus

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