At a Glance
- Tasks: Provide quality consultancy for medical devices and ensure compliance with regulations.
- Company: Join LFH, a leading medical device consultancy with a dynamic team.
- Benefits: Competitive salary, bonus scheme, health benefits, and professional development opportunities.
- Other info: Fully remote role with occasional travel and excellent career growth potential.
- Why this job: Make a real impact in the medical technology field while enhancing your skills.
- Qualifications: Degree or relevant experience in quality assurance within medical devices.
The predicted salary is between 40000 - 50000 £ per year.
Are you an experienced quality assurance professional looking for a new challenge? If so, we have just the opportunity for you! LFH is a top medical device consultancy company that is seeking a permanent Quality Assurance Consultant. You MUST be based in the UK.
What benefits will you get?
- Competitive Salary and compensation package: A salary of up to £50k pro rata depending on experience.
- Company based bonus scheme.
- Life Insurance.
- Health benefits.
- Professional growth and development: You’ll have the opportunity to work on a diverse range of projects, from writing and editing regulatory documents to providing oversight for outsourced deliverables to our clients.
- Stimulating work environment: Join a team at the forefront of medical device & IVD regulation, where every day brings new challenges and opportunities to make a difference and learn new things.
About LFH Regulatory: We work with varying companies that have diverse ranges of technologies which offers a stimulating work environment, and ample opportunities for professional growth and development. If you like working from home, know that this job is fully remote but with occasional travel.
Key purpose of the role:
- To provide Medical Device and IVD Quality consultancy for LFH Regulatory and its associated clients.
- Fully support LFH Regulatory clients in ensuring required product portfolio are compliant with all regional regulations.
- Implement and Maintain LFH Regulatory clients Quality Management System (QMS) in order to ensure compliance to all relevant regulatory and quality requirements.
Client facing responsibilities include but are not limited to:
- Attend client meetings both remote and onsite as needed.
- Implement full and partial quality management systems, that align with UK, EU, and US requirements/ISO 13485/21 CFR, by creating/writing procedures, controlled forms, and work instructions.
- Maintain client quality management systems and provide QMS support to clients.
- Conduct gap assessments and audit quality management systems.
- Provide support to clients pre, during and post audit, including audit preparation, attending audits and assisting with non-conformities.
- Work within LFH Regulatory’s eQMS, including help with implementation, improvements and maintenance.
- Liaise with notified/approved bodies and competent authorities.
LFH responsibilities include but are not limited to:
- Attend and participate in team meetings both remote and face to face.
- Create blog content for LinkedIn/Website and any other form of social media where required.
- Create, update, and maintain internal LFH Regulatory business processes and document employee training records.
- Attend exhibitions, conferences and network events.
Qualifications / skills required:
- Degree educated or relevant industry experience.
- Scientific, Engineering or Medical background with quality experience within the medical devices/IVD sector (ideally 2 or more years’ experience).
- Substantial experience in the implementation and maintenance of paper based quality management systems and electronic quality management systems.
- Comprehensive understanding and Implementation of ISO 13485 and/or FDA 21 CFR Part 820 into quality management systems from inception and/or to upgrade existing systems.
- ISO 13485 Auditor certification.
- Experience with electronic quality management systems.
- Must work well within a team with good interpersonal and communication skills.
- Excellent attention to detail is essential.
- Suitable general IT skills.
Quality Assurance Consultant in Huddersfield employer: LFH Regulatory Limited
LFH is an exceptional employer for Quality Assurance Consultants, offering a competitive salary and comprehensive benefits package, including a company bonus scheme and health benefits. With a fully remote work model and opportunities for professional growth in the dynamic field of medical device regulation, employees thrive in a stimulating environment that encourages collaboration and innovation, making a meaningful impact on healthcare technology.
