Job Description

Noah Medical is seeking a Director of RA/QA to lead the RA/QA function, providing guidance and leadership from a Regulatory and Quality perspective throughout all stages of product development. The ideal candidate will be a self-starter, team builder, and excellent in communication, with a passion for career growth.

Responsibilities

• Establish RA/QA department operational objectives/budgets and manage staff.
• Develop, modify, and execute RA/QA related company policies.
• Manage the RA/QA department functions through direct reports.
• Interact with senior management, suppliers, and/or customers to collaborate and problem solve.
• Support defining, training, and implementing the quality management system (QMS).
• Coordinate regulatory activities related to Design/Development/NPI, manufacturing, distribution control, and service.
• Manage the reporting and investigation of customer/service complaints and corrective actions.
• Serve as the designated Management Representative.

Requirements

• BS in Engineering or Technology (Mechanical, Industrial, Manufacturing, Electrical, Life Sciences, etc.).
• Minimum of 10 years of RA/QA related experience in the medical device field.
• Minimum of 3 years of supervisory experience.
• Experience working in a startup environment with NPI and product launch teams.
• Experienced in implementing a complete QMS system to meet US FDA and ISO requirements.
• Experienced in conducting internal and supplier audits and hosting 3rd party audits.
• Self-starter, team builder, and excellent in verbal and written communication.
• Knowledge of sterile/disposable medical device production processes (preferred).
• Master Degree, MBA, experienced with Software Validation (preferred).
• Certifications is a plus: CQE, CQA(BM), CQM, 6 Sigma, ISO Auditor, etc.

Benefits

• No benefits