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: We understand the value of your skills and expertise. We offer?
- 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. You will be able to enhance your skills and broaden your knowledge in the field of medical device regulation.
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. Collaborate with cross-functional teams and contribute to the development of crucial quality documents that impact the advancement of medical technology.
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.
Our services include device development and CE/UKCA marking certification, global regulatory strategies, US FDA, quality management system creation and ongoing support to ISO 13485, internal/supplier audits, remediating audit findings, technical documentation, risk management activities to ISO 14971, clinical requirements, recalls and adverse event management, product registration, and UK Responsible Person services.
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.