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
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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
#J-18808-Ljbffr
