Senior Quality Manager

Real Staffing; Cambridgeshire and Peterborough; On-site; GBP 40,000 - 60,000; Full time

Job summary

An established industry player in the medical device field is seeking a Senior Quality Manager to lead quality operations. This pivotal role involves ensuring regulatory compliance and managing a dedicated team to maintain high standards of quality in manufacturing processes. You will be responsible for implementing quality management systems, conducting audits, and promoting awareness of regulatory requirements across the organization. This is an exciting opportunity to make a significant impact in a dynamic environment, where your leadership and expertise will drive continuous improvement and uphold the highest quality standards in medical devices.

Qualifications

• Degree educated or practical expertise in Quality Management.
• Experience in Quality Management within Medical Devices.

Responsibilities

• Oversee daily quality operations ensuring regulatory compliance.
• Manage quality management system according to ISO 13485.

Skills

Quality Management

Internal/External Audit Expertise

People Management

Regulatory Compliance

Education

Degree in Quality Management or related field

Job description

Senior Quality Manager (PR/521948) Cornwall, England

Our client, a global Medical Device manufacturing company, is looking for a Senior Quality Manager to join an existing team reporting to the Head of QA. The company produces equipment, consumable medical devices, and general laboratory equipment utilized in surgical settings and fem tech. This is a cross-functional role where the chosen candidate will manage a team while working with internal and international teams/departments.

As the Senior Quality Manager, you will be responsible for overseeing the daily quality operations at the manufacturing site, ensuring regulatory compliance, implementation, and consistent performance of quality requirements.

Responsibilities:

• Ensure monitoring and correction of the quality management system according to ISO 13485.
• Act as management representative for the QMS.
• Ensure QMS processes are established, implemented, and maintained.
• Report to senior management on the QMS performance and where improvements are needed.
• Ensure everyone in the organization is aware of customer requirements.
• Promote awareness of applicable regulatory requirements related to QMS in the company.
• Ensure regulatory compliance regarding the EU MDR and its verification in line with QMS.
• Ensure conformity of medical devices is checked in accordance with the QMS before release.
• Comply with post-market surveillance obligations in accordance with MDR.
• Fulfill reporting obligations referred to in Articles 87 to 91 of the MDR.
• Update and maintain the Quality manual.
• Control and manage all CAPA activities and execute internal audits.
• Coach, train, and guide peers and team members; team management and stakeholder management is a key element of the position.
• Establish KPIs to track and measure performance of the QMS where needed.
• Review metrics and utilize a statistical approach when providing feedback to the business.
• Oversee document control procedures including preparation and review of quality policies.
• Become an active part of the site leadership team.
• Assist and mentor wider teams/departments on local and global manufacturing Medical device standards.

Qualifications/Skills:

• Ideally degree educated or similar practical expertise in Quality Management.
• Quality Management experience within a licensed manufacturer of Medical Devices.
• Internal/External audit expertise, preferably a certified internal auditor (although not a deal breaker).
• People Management skills.
• Ability to work on-site at least 4 days a week as this is a manufacturing role.

Application Details:

Name: Please include your first and last name.

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CV / Resume: Please confirm your eligibility to work in the country to which you are applying.