Senior Director Of Quality Assurance

The Senior Director of Quality Assurance will provide strategic and expert direction, management and alignment of all quality functions at CardioKinetix including Quality Assurance, Quality Engineering, Quality Control, Compliance and Document Control to ensure overall compliance with applicable national and international regulations, standards and best practices Areas of responsibilities include but are not limited to Quality System Procedures Compliance, External/Internal Audit Management, Management Review Process, CAPA Program, Complaint Handling, Supplier Management, Documents/Records Management, Training, Finished Goods Release/Distribution Control, Product Recall/Advisory Notice Management, Inspection/Test Method Development/Validation, Design Control, Risk Management, Change Control, Post CE Mark Requirements, Vigilance Reporting and Post Market Surveillance. He/she will develop strategies to ensure best in class compliance with applicable national and international regulations, standards and best practices, such as the FDA QSR, ISO 13485, MDD, and the CMDR. This key position will be primarily responsible for quality activities in preparation for a successful PMA pre approval inspection. May also play an integral role in the preparation of the manufacturing module for the PMA.

POSITION RESPONSIBILITIES

  • Serve as CardioKinetix’s Management Representative; provide quality system metrics on an on-going basis to Senior Management during Management Review meetings.
  • Ensure the quality system infrastructure is established/maintained in accordance with current applicable regulations and standards.
  • Prepare and lead CardioKinetix during all internal and external audits to achieve successful results (e.g. FDA, Notified Body, relevant state and international agencies, internal audits).
  • Routinely evaluate the existing quality system; set future direction to improve product/process quality and ensure alignment with organization objectives.
  • Identify opportunities to streamline quality system processes; successfully build organizational consensus in adopting newly proposed processes.
  • Ensure effective development and implementation of methods and procedures for inspection, testing, evaluation and release of components, subassemblies, and finished products.
  • Assess staff strengths and skills; plan for personnel growth opportunities, including skill enhancement, cross-training, and overall personnel development.
  • Manage quality resources, including personnel, equipment, and budget in alignment with departmental and corporate goals.
  • Provide input and support all regulatory submissions, and support/facilitate Regulatory Affairs activities as directed by the VP of RA/CA/QA.
  • Correspond with CardioKinetix Authorized Representative(s) and provide all pertinent documents to ensure regulatory compliance.
  • Support special projects as needed.

SKILLS & EXPERIENCE

Education:

Bachelor’s degree in life sciences, engineering or equivalent and 10+ years of related work experience or an equivalent combination of education and work experience.

Skills/Experience:

  • 10+ years of related experience in a regulated industry.

LOCATION

Menlo Park, CA