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- Tasks: Lead quality assurance efforts and maintain ISO accreditations in a dynamic medical equipment environment.
- Company: Join a leading Medical Equipment Manufacturing organization focused on innovative patient sampling solutions.
- Benefits: Enjoy a hybrid working model with flexibility and opportunities for professional growth.
- Why this job: Be part of a growing team that values quality and innovation in healthcare.
- Qualifications: 5+ years in Quality Assurance Management with strong ISO knowledge and medical device experience required.
- Other info: Collaborate with senior leadership to set quality benchmarks and drive improvements.
The predicted salary is between 48000 - 72000 £ per year.
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CPL are working with a leading Medical Equipment Manufacturing organisation with a growing workforce and expanding requirements for remote patient sampling, they require a Senior Quality Assurance Manager to join the team to achieve their ambitious growth in the coming years.
This position is based out of Croydon operating on a hybrid working model.
Responsibilities
Responsibility of the Management Representative for the ISO:13485 accreditation
Maintain accreditations for ISO:13485, ISO: 9001, ISO:14001, ISO:27001, and FSC
Oversee the business’ performance and activities to maintain GDP standards and maintain an MHRA WDA license
Collaborate with the Senior Leadership Team to set quality benchmarks, the effectiveness of the quality management system and improvements required
Identify and review Quality issues, develop proposals, and make decisions with input from the QA team
Promote and approve processes and procedures in accordance with industry standards and customer expectations
Competency requirements
Strong knowledge of ISO:13485, ISO:9001, ISO:27001
Knowledge of GDP working practices
Understanding of and ability to determine relevance of governmental regulatory processes and regulations.
5+ years of medical device industry experience, in Quality Assurance Management
Broad knowledge of ISO 13485:2016, US FDA, and European Medical Device Regulations (MDD, MDR, IVDD, IVDR)
Strong organization, communication, and problem-solving skills
Apply
Full name Email address Cover Message (optional) Upload CV Choose File Upload your CV and any other relevant file. Contact via SMS (optional) I would like to be contacted via SMS Privacy Policy I have read and agree to the Clinical Professionals Group Privacy Policy
Overview
CPL are working with a leading Medical Equipment Manufacturing organisation with a growing workforce and expanding requirements for remote patient sampling, they require a Senior Quality Assurance Manager to join the team to achieve their ambitious growth in the coming years.
This position is based out of Croydon operating on a hybrid working model.
Responsibilities
Responsibility of the Management Representative for the ISO:13485 accreditation
Maintain accreditations for ISO:13485, ISO: 9001, ISO:14001, ISO:27001, and FSC
Oversee the business’ performance and activities to maintain GDP standards and maintain an MHRA WDA license
Collaborate with the Senior Leadership Team to set quality benchmarks, the effectiveness of the quality management system and improvements required
Identify and review Quality issues, develop proposals, and make decisions with input from the QA team
Promote and approve processes and procedures in accordance with industry standards and customer expectations
Competency requirements
Strong knowledge of ISO:13485, ISO:9001, ISO:27001
Knowledge of GDP working practices
Understanding of and ability to determine relevance of governmental regulatory processes and regulations.
5+ years of medical device industry experience, in Quality Assurance Management
Broad knowledge of ISO 13485:2016, US FDA, and European Medical Device Regulations (MDD, MDR, IVDD, IVDR)
Strong organization, communication, and problem-solving skills
Apply
Full name Email address Cover Message (optional) Upload CV Choose File Upload your CV and any other relevant file. Contact via SMS (optional) I would like to be contacted via SMS Privacy Policy I have read and agree to the Clinical Professionals Group Privacy Policy
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Senior QA Manager employer: TN United Kingdom
Contact Detail:
TN United Kingdom Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior QA Manager
✨Tip Number 1
Make sure to highlight your experience with ISO standards in your conversations. Since the role requires strong knowledge of ISO:13485, ISO:9001, and ISO:27001, be prepared to discuss specific examples of how you've implemented these standards in previous roles.
✨Tip Number 2
Familiarize yourself with the latest trends and regulations in the medical device industry. Being able to discuss recent changes in MDD, MDR, IVDD, and IVDR will show that you are proactive and knowledgeable about the field.
✨Tip Number 3
Prepare to demonstrate your problem-solving skills through real-life scenarios. Think of specific quality issues you've encountered and how you resolved them, as this will showcase your ability to handle challenges effectively.
✨Tip Number 4
Network with professionals in the medical device sector. Engaging with others in the industry can provide insights into the company culture and expectations, which can be beneficial during your discussions with us.
We think you need these skills to ace Senior QA Manager
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Senior QA Manager position. Understand the key responsibilities and competencies required, especially regarding ISO standards and quality management systems.
Highlight Relevant Experience: In your CV and cover letter, emphasize your 5+ years of experience in the medical device industry, particularly in Quality Assurance Management. Provide specific examples of how you've maintained ISO accreditations and improved quality processes.
Showcase Your Knowledge: Demonstrate your strong knowledge of ISO:13485, ISO:9001, and other relevant regulations in your application. Mention any specific projects or achievements that illustrate your expertise in these areas.
Tailor Your Application: Customize your CV and cover letter to reflect the language and requirements mentioned in the job description. Use keywords related to quality assurance, regulatory compliance, and collaboration with leadership teams to make your application stand out.
How to prepare for a job interview at TN United Kingdom
✨Showcase Your ISO Knowledge
Make sure to highlight your strong knowledge of ISO:13485, ISO:9001, and ISO:27001 during the interview. Be prepared to discuss specific examples of how you've maintained these accreditations in previous roles.
✨Demonstrate Leadership Skills
As a Senior QA Manager, you'll be collaborating with the Senior Leadership Team. Share experiences where you've successfully led teams or projects, focusing on how you set quality benchmarks and drove improvements.
✨Prepare for Regulatory Questions
Expect questions about governmental regulatory processes and regulations. Brush up on your understanding of GDP working practices and be ready to explain how you've navigated these in past positions.
✨Problem-Solving Scenarios
Be ready to discuss specific quality issues you've identified and resolved. Prepare a few scenarios that demonstrate your problem-solving skills and how you made decisions with input from your QA team.
