Manager, Quality – Manufacturing
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Job Description
Manager overseeing quality and manufacturing engineering functions for hardware products at Hello Heart. Ensuring production readiness and product quality from prototype through mass production.
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
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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