Neptune Medical

Neptune Medical

Senior Operations Quality Engineer

Burlingame, California, United States · Senior

Sponsorship not specifiedDetected 22 days ago
ERPMechanical DesignGMPFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingMentoring

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odds of building a lasting career here

37Risky
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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Employer immigration record

from this employer's Department of Labor filings

Files H-1B transfers

3 transfer filings in the last year, covering 3 workers. Median labor-condition decision: 9 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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About the role

  • The Senior Operations Quality Engineer is responsible for supporting volume production, product introductions, and continuous improvements for assembly processes to achieve company initiatives for commercial success, value creation, and operational excellence.
  • The role involves working closely with production, quality control, and cross-functional teams to improve operational efficiency, reduce production costs and ensure product quality standards are met.
  • Responsible for sterilization related processes including validation, record verification, etc.

Responsibilities

  • Identify opportunities for, lead, and implement innovative solutions for quality improvements, cost reduction, scaling production, and production efficiency that reduce risk and optimize production performance.
  • Support and provide expertise regarding validation (IQ/OQ/PQ) activities and similar qualifications and generate detailed technical reports.
  • Provide technical quality support to the production floor and incoming/in-process quality control areas to address any issues.
  • Leverage statistical methods and software to support data-driven decisions, including for part acceptance and product release.
  • Lead NCR and CAPA efforts.

Requirements

  • Strong knowledge of inspection methods and manufacturing processes, including assembly and testing.
  • Proficiency in statistical software (e.g., Minitab, JMP) for product design and process optimization.
  • Familiarity with EDMS, ERP systems, and manufacturing software.
  • Proven experience in cross-functional team collaboration
  • Knowledge of relevant industry regulations, quality standards, and safety protocols.
  • Author and maintain inspection documentation, including protocols, reports, Quality Inspection Procedures (QIPs), work instructions (WIs), test methods (TMs) and, if required component/product drawings.

Nice to have

  • Bachelor's degree in Manufacturing Engineering, Biomedical Engineering, Mechanical Engineering, or a related field (Master's degree preferred).
  • 3+ years of experience in manufacturing or operations preferred.

Compensation

  • The starting base salary for this role is between $150,000 and $190,000 depending on experience.

Company info

  • a fully flexible medical robot that enables doctors to reach deep into human anatomy.
  • Our robot will disrupt flexible endoscopy and set a new standard in outcomes for decades to come.
  • Operations Quality Engineer

This listing is sourced directly from Neptune Medical's careers page and normalized into a canonical job model.