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Salary Are you interested in working on products at the very cutting edge of technology? Want to join Vicon, an Academy Award®-winning company, and the world’s largest supplier of precision motion capture and tracking systems?
Vicon is the world leader in motion capture technology, developing high performance software and hardware products for the entertainment, engineering and life science industries. Vicon products have been used in major feature films, games, and commercials, and Vicon is a crucial measurement tool for biomechanics, robotics, and cutting-edge science. We have offices in Oxford, Denver, Los Angeles and New Zealand.
Vicon is a subsidiary of Oxford Metrics Plc.
Reporting to Vicon’s Head of Quality and Regulatory Compliance, the QMS Manager, will play a pivotal role in ensuring the effective implementation and maintenance of the Quality Management System (QMS) across our organization. You will be responsible for overseeing all aspects of quality management, including compliance with relevant regulations and standards. This role requires a detail-oriented individual with strong leadership skills and a desire to drive continuous improvement in quality processes.
Key Responsibilities
1. Develop, implement, and maintain the QMS in accordance with ISO 9001, ISO 13485, UK MDR 2002 & (EU) MDR 2017/745.
2. Ensure compliance with applicable regulations and standards, including FDA regulations, (EU) 2017/745, UK MDR 2002 and other relevant requirements.
3. Lead internal audits, support external audits and ensure timely resolution of audit findings and corrective actions.
4. Establish and maintain quality policies, procedures, and documentation to support compliance with regulatory requirements. Management of QMS Processes such as NC, CAPA and Change.
5. Collaborate with cross-functional teams to integrate quality considerations into product development processes.
6. Provide training and guidance to employees on quality management principles and regulatory compliance requirements.
7. Monitor and analyse quality metrics to identify areas for improvement and drive continuous improvement initiatives.
8. Serve as the primary point of contact for quality-related inquiries from regulatory authorities and customers.
9. Stay informed about changes in regulations and standards relevant to our industry and ensure timely implementation of necessary updates to the QMS.
Required Skills, Knowledge and Expertise
· Bachelor's degree in a relevant field (e.g., Engineering, Quality Management, Regulatory Affairs).
· Minimum of 4 years of experience in quality management within the medical device industry. Experience with implementing and maintaining Quality Management Systems (QMS) in accordance with ISO standards.
· Knowledge of ISO Standards including ISO 13485, ISO 9001, ISO 14971, IEC 62304 and EN 60601.
· Knowledge of global regulatory requirements applicable to the company's products and services, such as (EU) 2017/745, UK MDR 2002, FDA regulations, etc.
· Excellent communication and interpersonal skills, with the ability to interact effectively with employees at all levels of the organization.
· Detail-oriented mindset with a focus on continuous improvement and driving results.
· Certification in Quality Management or Auditing is a plus.
· Experience with tools like SharePoint, Confluence and Jira.
Benefits
· Competitive salary
· 10% Company Pension
· 25 days Annual Leave + Bank Holidays
· Life Cover
· Private Medical with Optical / Dental Insurance
· Permanent Health Insurance
· Cycle to work scheme.
· Free On-site Parking
About Vicon Motion Systems Limited
Vicon is the world leader in Motion Capture, developing high performance software and innovative hardware products for the entertainment, engineering and medical industries. Vicon systems are a crucial tool for measurement and 3D tracking for cutting-edge science including biomechanics, robotics and virtual or augmented reality. Vicon products have been used in many major feature films, video games and commercials. We have offices in Yarnton, Denver, Los Angeles and Auckland.
Vicon Motion Systems Ltd is a subsidiary company of Oxford Metrics Plc.
Department
Vicon Quality & Regulatory Compliance
Employment Type
Permanent - Full Time
Location
Yarnton, Oxfordshire
Workplace type
Hybrid
Reporting To
Pablo Callejo
This role's hiring manager:
Pablo Callejo
View Pablo's Profile
