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Sr. Quality Engineer

Company Name: Nihon Kohden OrangeMed, Inc.
Location: Santa Ana, CA
Job Type: Full-time
Contact Name: Sheryl Higgins
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary: Commensurate with Experience

Job Description

Nihon Kohden OrangeMed, Inc. is looking for a Sr. Quality Engineer to be an integral member of the quality department as we transition our focus from R&D to Manufacturing.

Assigned responsibilities include:

• Implementation and maintenance of company Quality System in compliance with US-FDA, MDD/MDR, ISO 13485 and other applicable country specific medical device regulations.
• Conduct internal quality audits to ensure compliance to Quality System and regulatory requirements.
• Control of suppliers including supplier approval, supplier audits, supplier monitoring and supplier corrective action.
• Assist with Agency Inspections and Notified Body certification/recertification audits.
• Implementation and maintenance of company corrective action / preventive action system.
• Implementation and maintenance of company complaint system.
• Preparation and submission of MDR and Vigilance adverse event reports.
• Work with R&D and Manufacturing Engineers on implementation of design changes/process improvements including V&V activities, production transfer and sustaining engineering.
• Understand and manage company’s electronic documentation system with the goal of transferring paper-based quality systems to electronic-based.
• Collection and trending of key quality indicators for management review.
• Perform other related functions as required by management.

Job Requirements

• Bachelor’s degree in a technical field such as Engineering or Biological Science and a minimum of five-years experiences in the field of medical electronics manufacturing, prior experience with mechanical ventilators preferred;
• Proficient understanding of ISO 13485 requirement and its practical application;
• Ability to read and interpret engineering drawings, schematics and specifications;
• Motivated, detail oriented, and well-organized with good communication skills, both written and oral;
• Proficient computer skills which include the use of Microsoft WORD, EXCEL (including pivot tables), and POWERPOINT. Prior use of an electronic document control system, ERP system and FDA eMDR reporting.
• Must be able to type using the keyboard of a computer. Must be able to talk, listen and speak clearly on the telephone. Must be able to lift and carry up to 50 lbs. Occasional travel may be required.

Desirable Accreditations/Knowledge:
• ASQ Certifications such as Quality Engineer (CQE), Quality Auditor (CQA), Six Sigma Black Belt (CSSBB), Supplier Quality Professional (CSQP), etc.
• Certified ISO 13458 / MDD lead auditor.


Nihon Kohden OrangeMed, Inc. offers a full benefits package including medical, vision, dental, life insurance, 401k with company match, along with a competitive salary and participation in the company bonus program.

If you are interested please send your resume to: This email address is being protected from spambots. You need JavaScript enabled to view it.