Lead Auditor 13485

Lead Auditor 13485

Full-Time 36000 - 60000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Lead audits and consultancy for ISO 13485:2016 in medical devices.
  • Company: IMSM is a top-tier ISO specialist dedicated to world-class consultation.
  • Benefits: Join a dynamic team with opportunities for growth and skill development.
  • Why this job: Make an impact in the medical device industry while enhancing your expertise.
  • Qualifications: Must have IRCA 13485:2016 Lead Auditor certification and strong implementation experience.
  • Other info: Ideal for ambitious professionals looking to excel in quality assurance.

The predicted salary is between 36000 - 60000 £ per year.

Do you have ISO 13485:2016 Medical Devices experience?

IMSM is one of the world’s leading ISO specialists. To continue the expansion of our operations, we are keen to meet enthusiastic, ambitious and hardworking professionals to help us reach and exceed our high targets. As an organization, we work towards a common goal: to consistently deliver to our client’s world-class consultation, reinforced by adherence to our IMSM Mission, Vision, and Values.

Who are we looking for?

You must be a highly qualified, competent Lead Consultant with a background and full experience of implementation and auditing in medical devices.

We work across industries with businesses of all sizes, so your own commercial and/or industrial experience will be important as you interface with our clients. You will be responsible for carrying out consultancy and auditing work as per contractual arrangements as laid out in the current version of the Consultant Handbook.

Responsibilities:

  1. Where necessary, you will be tasked with making presentations and preparing assessment reports outlining the findings of the assessment to ensure the client has a clear understanding of the assessment decision.
  2. You will be able to identify a clear direction to correct any items where appropriate as per current contractual arrangements.
  3. You will be required to provide accurate and prompt information to support services to ensure that client records are up to date and complete and that all internal information requirements are met.
  4. You will be expected to maintain and develop your own skills and knowledge both technologically and in the field of Management and standards.

Person Specification:

  • IRCA 13485:2016 Lead Auditor certification or equivalent
  • Must have strong implementation experience
  • Excellent written and verbal communication skills
  • Be highly organized and ensure relevant paperwork is completed effectively
  • An individual who is adaptable and flexible to respond to client needs

Seniority level

Mid-Senior level

Employment type

Other

Job function

Quality Assurance, Business Development, and Consulting

Industries

Business Consulting and Services

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Lead Auditor 13485 employer: IMSM

IMSM is an exceptional employer that values the expertise and dedication of its team members, particularly in the field of ISO 13485:2016 for medical devices. Our collaborative work culture fosters professional growth and development, offering ample opportunities for training and advancement while working alongside industry leaders. Located in a dynamic environment, we provide our employees with the resources and support needed to excel in their roles, ensuring a fulfilling and rewarding career path.
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Contact Detail:

IMSM Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Lead Auditor 13485

✨Tip Number 1

Make sure to highlight your ISO 13485:2016 experience in conversations with industry professionals. Networking at relevant conferences or seminars can help you connect with potential employers and showcase your expertise.

✨Tip Number 2

Prepare to discuss specific examples of your auditing and implementation experiences during interviews. Being able to articulate how you've successfully navigated challenges in the medical devices sector will set you apart.

✨Tip Number 3

Stay updated on the latest trends and changes in ISO standards, especially those related to medical devices. This knowledge will not only enhance your credibility but also demonstrate your commitment to continuous learning.

✨Tip Number 4

Practice your presentation skills, as you may be required to present findings to clients. Being confident and clear in your communication will help you make a strong impression during the interview process.

We think you need these skills to ace Lead Auditor 13485

ISO 13485:2016 Expertise
IRCA 13485:2016 Lead Auditor Certification
Implementation Experience in Medical Devices
Excellent Written Communication Skills
Strong Verbal Communication Skills
Organizational Skills
Attention to Detail
Client Relationship Management
Presentation Skills
Assessment Report Preparation
Adaptability and Flexibility
Knowledge of Quality Assurance Standards
Problem-Solving Skills
Technological Proficiency in Relevant Tools

Some tips for your application 🫡

Highlight Relevant Experience: Make sure to emphasize your ISO 13485:2016 experience in your application. Detail your background in implementation and auditing of medical devices, as this is crucial for the role.

Showcase Communication Skills: Since excellent written and verbal communication skills are essential, include examples of how you've effectively communicated findings or presented assessments in previous roles.

Organizational Skills: Demonstrate your organizational abilities by mentioning specific instances where you managed paperwork or client records efficiently. This will show that you can handle the responsibilities of the position.

Adaptability and Flexibility: Provide examples of how you've adapted to client needs in past roles. This will illustrate your ability to be flexible and responsive, which is a key requirement for the job.

How to prepare for a job interview at IMSM

✨Showcase Your ISO 13485 Experience

Make sure to highlight your specific experience with ISO 13485:2016 during the interview. Prepare examples of past projects where you successfully implemented or audited medical devices, as this will demonstrate your competence and relevance to the role.

✨Prepare for Technical Questions

Expect technical questions related to ISO standards and auditing processes. Brush up on your knowledge of the latest regulations and be ready to discuss how you have applied them in real-world scenarios.

✨Demonstrate Strong Communication Skills

Since the role involves making presentations and preparing assessment reports, practice articulating your thoughts clearly and concisely. Be prepared to explain complex concepts in a way that is easy for clients to understand.

✨Emphasize Adaptability and Client Focus

IMSM values professionals who can adapt to client needs. Share examples of how you've been flexible in previous roles and how you prioritize client satisfaction while maintaining high standards in your work.

Lead Auditor 13485
IMSM
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  • Lead Auditor 13485

    Full-Time
    36000 - 60000 £ / year (est.)

    Application deadline: 2027-04-18

  • I

    IMSM

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