NIHON KOHDEN OrangeMed · 1 hour ago
Director, Quality Assurance
Santa Ana, CA
Full-time
Onsite
Director/Executive
$155K/yr - $188K/yr
10+ years expNIHON KOHDEN OrangeMed is seeking a Director of Quality Assurance to lead and oversee the company's quality strategy. This role involves ensuring product and process compliance with regulations, driving continuous improvement initiatives, and fostering a culture of quality throughout the organization.
ManufacturingMedicalMedical Device
Responsibilities
Lead the Quality Assurance department; select, manage, develop, and hold accountable team members to meet department deliverables and responsibilities
Control of suppliers including supplier approval, supplier audits, supplier monitoring and supplier corrective action
Support sustaining engineering of commercialized product from a quality perspective
Support development and design transfer of new products to production from a quality perspective
Manage the document change control process. Review and approve changes to engineering drawings, specifications and procedures. Assess impact on design and processes from a regulatory standpoint
Manage QA Engineering activities (including Design/Development and Sustaining)
Lead Risk Management activities ensuring compliance with ISO 14971, including but not limited to the completion of FMEAs, Risk Assessments, and Risk Management Plans/Reports
Lead material review board (MRB). Facilitate non-conforming material report (NMR) documentation, material disposition and NMR closure
Monitor and maintain corrective action / preventive action system
Conduct internal quality audits to ensure compliance to Quality System and regulatory requirements
Ensures maintenance of company Quality System is in compliance with US-FDA, MDD/MDR, ISO 13485 and other applicable country specific medical device regulations
Function as a company liaison with regulatory and/or Notified Bodies during certification/recertification audits
Collection and trending of key quality indicators for management review
Assist with regulatory submissions and technical file creation/maintenance for new products and significant changes, as needed
Adheres to all company policies, procedures and business ethics codes
Duties may be modified or assigned at any time based on business needs
Qualification
Required
Bachelor's degree in a technical field such as Engineering or Biological Science and a minimum of ten-years' experience in the field of medical device quality/manufacturing, prior experience with medical electronics preferred
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, and POWERPOINT. Prior use of an electronic document control system, ERP system and FDA eMDR reporting
Certified ISO 13485 Lead Auditor or equivalent
Proficient understanding of FDA / MDD / MDR Regulations
Minimum 5 years of people management experience, including driving results through others, leading team or projects, provide training and guidance
Preferred
ASQ Certifications such as Manager of Quality/Organizational Excellence, Quality Engineer, Quality Auditor, Supplier Quality Professional, etc
Completion of MDR Certified training course or equivalent
Company
NIHON KOHDEN OrangeMed
Nihon Kohden Orangemed focuses on the design and development of respiratory products.
201-500 employees
Funding
Current Stage
Growth StageRecent News
2024-12-29
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