What you do:
The most senior position responsible for Quality relating to the manufacture and distribution of medical devices. Responsible for ensuring compliance to EN ISO 13485: 2016 and adherence to the FDA Quality Systems Regulation (21 CFR Part 820) and other FDA Regulations as well as interacting with the FDA and other regulatory agencies related to all quality management system aspects. Support of Quality Engineering for manufacturing to ensure finished products conform to all government and company standards and satisfy all FDA, MDD and other international regulations.

Directs and oversees the development and implementation of standards, methods and procedures for inspecting, testing, and evaluating the precision, accuracy and reliability of company products.  Responsible for directing, establishing and maintaining quality standards for all products based on internal and external specifications. 

The Quality Director/Manager serves as the designated Management Representative as required by CFR 21 section 820.20(b)(3) of the Quality System Regulation (QSR) and ISO 13485. These responsibilities include  to: 

• Support manufacturing activities- prepare materials and documentation, support build activities, and review documentation.

• Perform device design reliability engineering activities including test equipment and fixture design, test setup, data analysis and reporting.

• Leverage engineering knowledge in conducting complaint evaluations and CAPA investigations to understand potential device failures

• Develop procedures and perform inspection on components and assemblies used to manufacture medical devices.

• Perform statistical analysis on inspection, and other performance testing metrics.

• Manage inventory tracking and transfers.

• Complete equipment and fixture qualification and preventive actions

• Support calibration activities, including recalls and maintenance of calibration files.

• Apply engineering principles to product design analysis and assessment.

Who you are:
The Quality Director/Manager administers and oversees the various elements of the quality system and the compliance audit function including responsibility to establish procedures for quality audits and to conduct such audits to assure that the quality system is in compliance with established quality system requirements of the quality system.

The Management Representative has authority over and responsibility for ensuring that quality system requirements are effectively established and maintained in accordance with the QSR and reporting on the performance of the quality system management with executive responsibility for review.

Minimum qualifications:

• Requires a Bachelor’s degree or equivalent, with a minimum of 10 years management experience in Quality or related areas.  Knowledge of FDA regulations, and the Quality Systems Regulation, and EN ISO 13485:2016 are essential

• Experience with medical device Quality Management Systems, and Design Controls

• Experience managing audits from regulatory authorities

• Experience managing teams within the Quality Management System

• Excellent verbal and written communication skills.

• Strong computer skills with MS office applications including Excel

• Experience with statistical data analysis in Excel, Matlab, JMP or Minitab.

• Collaboration in team environments.

• Strong team-player.

• Adaptability to a dynamic work environment.