Global QMS Director

Job Description Summary:

The Global QMS Director is responsible for developing, implementing and maintaining the Corporate QMS, ensuring compliance with regulatory standards (ISO 13485, ISO 14971, 21CFR820) and internal policies. This role requires a deep knowledge of medical device regulations, strong leadership capabilities, and commitment to maintaining the highest quality standards.

Job Responsibilities: QMS Development & Implementation

• Develop, maintain and enhance the Corporate Quality Management System in accordance with ISO 13485, FDA regulations and other applicable standards.
• Ensure that the Corporate QMS aligns with organizational objectives and integrates with all functional areas effectively
• Manage the Corporate change control process

Leadership and Training

• Lead and mentor a team of quality professionals across different locations to implement best practices and ensure alignment with the Corporate QMS

• Collaborate with cross-functional teams to instill a quality mindset
• Establish routine training sessions to ensure all employees understand quality objectives and processes

Quality Assurance and Compliance

• Stay updated on international quality standards and regulatory requirements relevant to the medical device industry.
• Champion improvement initiatives by working with teams to establish effective quality plans
• Employ statistical techniques and data analysis tools to inform decision-making and promote efficiencies
• Drive the development of KPIs to measure the QMS effectiveness.

Audit Management

• Manage internal and external audits to monitor compliance to the QMS
• Analyse audit findings, identify trends, and develop corrective action actions to prevent reoccurrence of issues.

Risk Management

• Implement risk management strategies through-out the product life cycle to comply with regulations and ensure issues are identified and mitigated

Required Education and Experience:

• Bachelor's degree in Engineering, Life Sciences, Quality Management or a related field.
• Minimum of 7 years of experience in quality management within the medical device industry with at least 3 years in leadership roles
• Extensive knowledge of FDA and ISO regulations, quality system standards, and best practices specific to medical devices.
• Proven track record in developing and implementing effective quality management systems.

Skills and Abilities Required for This Job:

• Strong analytical, problem-solving, and decision making skills.
• Excellent communication and interpersonal skills with the ability to influence and drive change at multiple organizational levels.

Salary & Benefits Package

• £100,000
• 15% Annual Bonus
• Signing Bonus
• 36 Days Holiday Inclusive of Bank Holiday
• AXA Private Health Care
• Remote with Business Travel