Job description

About the job
Director of Quality Assurance
The Director of Quality Assurance is responsible for the strategic development and execution of my client’s quality assurance and is accountable for the execution and administration of the quality assurance and compliance strategy, Quality Management Systems (QMS) and policies to assure compliance to FDA and international regulations across products and all regulatory audit and inspection activities.
The Director of Quality will:

Lead a dedicated team responsible for the quality oversight for the entire organization through the use of the quality management system and associated processes;
Ensure that the corporate policies and processes are appropriate for each phase of development, and comply with corresponding regulations; and
Oversee the development, implementation and management of a quality management system in accordance with ISO 13485, 21 CFR 820, EU MDR, and AIMD Directive 90/385/EEC.

The Director of Quality is the most senior quality role within my client’s quality team and is a strategic part of my client’s senior leadership team.
Responsibilities:

Oversee all aspects of planning, developing, and executing quality assurance policies, programs, and initiatives of my client’s Class III implantable device.
Oversee the development, implementation and management of a quality management system (QMS) in accordance with ISO 13485, 21 CFR 820, EU MDR, and AIMD Directive 90/385/EEC.
Establish audit and surveillance protocols to monitor the entire production process.
Develop training programs, standards, tools, and methods to foster a culture of quality within the company.
Provide regulatory guidance to R&D teams for assessing device and manufacturing changes.
Develop regulatory strategies and the writing, compiling and submission of regulatory documents to the FDA and other Regulatory Agencies.
Define, implement and manage the processes for quality supplier qualification of vendors.
Establish and chair Quality Management Review to ensure visibility and governance for the performance and improvement of the QMS.
Participate in development planning and resource management activities as required.
Assist in writing SOWs, NDAs and other supplier related contracts.
Manage my client’s quality engineers and quality assurance staff and contractors.
Establish and maintain a set of clearly documented quality systems, standards and procedures defining the requirements of products and to advise on the application of these requirements.
Direct and oversee the execution of the QMS specifically for Clinical and medical devices.
Execution and outcomes of quality audits, including internal systems and external vendors.
Accountable for quality interfaces end-to-end in the development process from early phase research to manufacture and commercial launch.
Interface with other disciplines including Clinical, Regulatory, Engineering, Project Management, and Manufacturing to ensure effective QMS transition between R&D and commercial processes.
Define, implement and manage the processes for Quality supplier qualification of vendors.
Ensure Quality Management Reviews occur within stipulated timelines and issues are escalated to the senior engineering team.
Oversee and participate in the writing, review, editing and compilation of regulatory submissions and quality documentation. Documents may include FDA submissions and IDEs for EFS, HDEs and PMAs, Supplements/ Amendments/Annual Reports, Change Notifications, Technical Files/Design Dossiers and responses to regulatory agencies’ questions and other correspondence
Maintain current and in-depth knowledge of FDA and Worldwide Regulatory Authority programs, policies and guidelines with the ability to work effectively across different cultures and markets.
Assure that all submission documentation, record keeping, and reporting meet inspection standards as established by regulatory agencies worldwide.

Requirements:

Bachelor’s Degree in a Life Science or Mechanical, Electrical or Biomedical Engineering.
Minimum 15 years of relevant experience in a QA leadership position in the medical industry, preferably in the implantable medical device development field.
10+ years of experience with a Class III medical device manufacturer.
Proven ability to deal effectively with regulatory agencies and notified bodies with coordination of product submissions and approvals.
Extensive knowledge and in-depth experience of implementation of quality management system.
A hands-on leader with managerial experience who leads by example, inspires, and empowers team members.

Lead a dedicated team responsible for the quality oversight for the entire organization through the use of the quality management system and associated processes;
Ensure that the corporate policies and processes are appropriate for each phase of development, and comply with corresponding regulations; and
Oversee the development, implementation and management of a quality management system in accordance with ISO 13485, 21 CFR 820, EU MDR, and AIMD Directive 90/385/EEC.

The Director of Quality is the most senior quality role within my client’s quality team and is a strategic part of my client’s senior leadership team.
Responsibilities:

Oversee all aspects of planning, developing, and executing quality assurance policies, programs, and initiatives of my client’s Class III implantable device.
Oversee the development, implementation and management of a quality management system (QMS) in accordance with ISO 13485, 21 CFR 820, EU MDR, and AIMD Directive 90/385/EEC.
Establish audit and surveillance protocols to monitor the entire production process.
Develop training programs, standards, tools, and methods to foster a culture of quality within the company.
Provide regulatory guidance to R&D teams for assessing device and manufacturing changes.
Develop regulatory strategies and the writing, compiling and submission of regulatory documents to the FDA and other Regulatory Agencies.
Define, implement and manage the processes for quality supplier qualification of vendors.
Establish and chair Quality Management Review to ensure visibility and governance for the performance and improvement of the QMS.
Participate in development planning and resource management activities as required.
Assist in writing SOWs, NDAs and other supplier related contracts.
Manage my client’s quality engineers and quality assurance staff and contractors.
Establish and maintain a set of clearly documented quality systems, standards and procedures defining the requirements of products and to advise on the application of these requirements.
Direct and oversee the execution of the QMS specifically for Clinical and medical devices.
Execution and outcomes of quality audits, including internal systems and external vendors.
Accountable for quality interfaces end-to-end in the development process from early phase research to manufacture and commercial launch.
Interface with other disciplines including Clinical, Regulatory, Engineering, Project Management, and Manufacturing to ensure effective QMS transition between R&D and commercial processes.
Define, implement and manage the processes for Quality supplier qualification of vendors.
Ensure Quality Management Reviews occur within stipulated timelines and issues are escalated to the senior engineering team.
Oversee and participate in the writing, review, editing and compilation of regulatory submissions and quality documentation. Documents may include FDA submissions and IDEs for EFS, HDEs and PMAs, Supplements/ Amendments/Annual Reports, Change Notifications, Technical Files/Design Dossiers and responses to regulatory agencies’ questions and other correspondence
Maintain current and in-depth knowledge of FDA and Worldwide Regulatory Authority programs, policies and guidelines with the ability to work effectively across different cultures and markets.
Assure that all submission documentation, record keeping, and reporting meet inspection standards as established by regulatory agencies worldwide.

Requirements:

Bachelor’s Degree in a Life Science or Mechanical, Electrical or Biomedical Engineering.
Minimum 15 years of relevant experience in a QA leadership position in the medical industry, preferably in the implantable medical device development field.
10+ years of experience with a Class III medical device manufacturer.
Proven ability to deal effectively with regulatory agencies and notified bodies with coordination of product submissions and approvals.
Extensive knowledge and in-depth experience of implementation of quality management system.
A hands-on leader with managerial experience who leads by example, inspires, and empowers team members.

Director Quality

Director Quality

Job description

James Cox