Director of Quality and Regulatory
Medical Devices

We are a fast-growing Medical Device Company with an IMMEDIATE full-time job opening for a Director of Quality and Regulatory Medical Devices.

Job Function:

Responsible for the QA function to ensure Quality Policy objectives are met. Also supports Regulatory Compliance of our medical device and R&D Company. Help assure that all products manufactured by the Company meet FDA, cGMP, ISO 13485 and other applicable standards and regulatory requirements.

Duties and Responsibilities:

• Perform QA functions to ensure facility compliance with the Company’s Quality Policy and all applicable external standards and regulatory requirements.
• Execute and maintain (keep up to date) the Company’s Quality Management System (QMS) and related records per current FDA cGMP regulations and the ISO 13485 standard.
• Manage Corrective and Preventive Action (CAPA), Document/Change control, Supplier control, Post-market Surveillance and other QA activities.
• Work closely with management to set and execute Quality Objectives.
• Work closely with engineering and manufacturing to ensure compliance. Help in providing guidance to engineering to support design controls and design transfer, acceptance of new products and manufacturing.
• Maintain the Design History Files for US compliance. Maintain the Technical Files, and Declarations of Conformity, for compliance with the European Medical Device Directive.
• Support regulatory submissions.
• Act as an Facility/Management Representative to external regulatory agencies.
• Perform due diligence internal and external audits to identify all significant QA deficiencies. Ensure the appropriate methods of measurement for detection of quality problems.
• Lead management reviews and provide inputs / report on the QMS performance for management reviews. Promote company-wide quality improvement efforts for uncompromised reliability and safety.
• Review and approve device labeling and market literature to ensure compliance.
• Provide ongoing QA training to our team. Help develop and deliver training modules. Maintain personnel training records.
• Other related duties as assigned.

Education and Skills:

• Bachelor’s degree or equivalent; in engineering, life sciences, technical or business-related field. Master’s degree is preferred.
• Seven years or more QA related experience in medical device industry.
• Knowledge in QMS, quality improvement and quality measurement standards.
• Knowledge of medical devices standards and regulations, including FDA cGMP, ISO 13485, European Medical Devices Directive/Medical Device Regulation and/or other national and international regulations.
• ISO 13485 Lead Auditor certification is strongly desirable.
• Experience in regulatory filings (510k and EU regulatory submissions) is strongly desirable.

Please email your cover letter and resume (with salary requirements) to our HR Department at IWantToWork@neurowavesystems.com