Director of Quality Assurance

Nihon Kohden Orange Med•Santa Ana, CA

4d•$155,000 - $188,000

About The Position

The Director of Quality Assurance will lead and oversee all aspects of the companys quality strategy, ensuring product and process compliance with applicable regulations and standards. This role is responsible for driving continuous improvement initiatives, maintaining certifications, and fostering a culture of quality throughout the organization.

Requirements

Bachelors 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 13458 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.

Nice To Haves

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.

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.