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- Tasks: Lead quality operations and manage a team in a dynamic medical device environment.
- Company: Join a global leader in medical device manufacturing, making a real impact in healthcare.
- Benefits: Enjoy competitive pay, career growth opportunities, and a collaborative work culture.
- Why this job: Be part of a mission-driven team ensuring quality in life-saving medical devices.
- Qualifications: Degree in Quality Management or relevant experience; people management skills are essential.
- Other info: On-site presence required for at least 4 days a week in Cornwall.
The predicted salary is between 48000 - 84000 £ per year.
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.
- 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.
Senior Quality Manager employer: Real Staffing
Contact Detail:
Real Staffing Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Manager
✨Tip Number 1
Familiarise yourself with ISO 13485 and the EU MDR regulations. Understanding these standards will not only help you in interviews but also demonstrate your commitment to quality management in the medical device sector.
✨Tip Number 2
Network with professionals in the medical device industry, especially those involved in quality management. Attend relevant conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the field.
✨Tip Number 3
Prepare to discuss your experience with CAPA activities and internal audits. Be ready to share specific examples of how you've successfully managed quality systems and improved processes in previous roles.
✨Tip Number 4
Showcase your people management skills by preparing examples of how you've coached and guided teams in the past. Highlight your ability to foster a culture of quality awareness and compliance within an organisation.
We think you need these skills to ace Senior Quality Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Quality Management, particularly within the medical device sector. Emphasise your familiarity with ISO 13485 and any auditing experience you have.
Craft a Compelling Cover Letter: Write a cover letter that showcases your leadership skills and experience in managing quality operations. Mention specific examples of how you've ensured regulatory compliance and improved quality management systems in previous roles.
Highlight Team Management Experience: Since this role involves managing a team, be sure to include details about your people management skills. Discuss how you've coached or trained team members and any successful outcomes from your leadership.
Showcase Your Knowledge of Regulatory Requirements: Demonstrate your understanding of EU MDR and post-market surveillance obligations in your application. This will show that you are well-versed in the necessary regulations for the role.
How to prepare for a job interview at Real Staffing
✨Understand the Regulatory Landscape
Familiarise yourself with ISO 13485 and EU MDR regulations. Be prepared to discuss how you have ensured compliance in previous roles, as this will demonstrate your expertise and understanding of the quality management system.
✨Showcase Your Leadership Skills
As a Senior Quality Manager, you'll be managing a team. Prepare examples of how you've successfully led teams in the past, focusing on coaching, training, and stakeholder management. This will highlight your ability to guide and motivate others.
✨Prepare for Technical Questions
Expect questions related to CAPA activities, internal audits, and document control procedures. Brush up on your technical knowledge and be ready to provide specific examples of how you've handled these processes in your previous roles.
✨Demonstrate Your Analytical Skills
Be ready to discuss how you've established KPIs and used statistical approaches to track QMS performance. Providing concrete examples of metrics you've reviewed and improvements you've implemented will show your analytical capabilities.
