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Scientific jobs in Essex

Displaying 1 - 3 of 3 jobs

£38000 - £42000 per annum

Harlow, Essex

6 days ago

Quality Assurance & Regulatory Affairs Manager - Medical Devices

A Quality Assurance & Regulatory Affairs Manager with detailed knowledge of medical devices is required by a leading manufacturer that develops chemical technology for the treatment of breathable gases.

This role will be a focal point in maintaining the compliance and effectiveness of the Business Quality Management System (BQMS).

You must be fully abreast with the applicable regulatory requirements and standards for the product, process and/or service developed, manufactured and provided.

It is essential for this role in driving continuous improvement whilst promoting/maintaining compliance culture throughout the organisation.



Responsibilities & Duties:

* Support the technical director in planning the quality & regulatory strategies of the company
* Deputise for technical director concerning quality matters
* Provide leadership to quality / regulatory team
* Facilitates deployment of quality approaches and methods in other functional areas
* Main responsible in managing and maintaining compliance with the applicable medical device regulations e.g. MDD 93/42/EEC, Canada SOR/98-282, US FDA 21 820 QSR, CFDA No. 650
* Main responsible in managing and maintaining conformance with ISO 9001 and ISO 13485 certifications
* Act as the main contact person in liaison with the national competent authorities and notified body
* Managing the application and/or renewal of product registration and licence
* Hosting management review meetings and report to senior management the overall performance of the Business Quality Management System (BQMS)
* Hosting of client/3rd party audits, and managing any non-conformances to satisfactory outcome
* Management and submission of technical files for manufactured medical products
* Evaluation and reporting to competent authority any adverse incident arising from customer complaints
* Providing quality/regulatory input in the NPD/EPD process
* Managing the internal audit programme and provide support to pool of auditors
* Leading/assisting the investigation of quality issues, customer complaints or product failure
* Carry out periodic review of procedures to ensure effectiveness of the processes is maintained
* Reviewing and approval of product labelling and marketing materials to ensure compliance with the applicable regulatory requirements
* Provide full regulatory support to export markets as required



Knowledge & Experience:

* Significant experience gained within a manufacturing environment within a regulated industry (medical device/drug)
* Knowledge of Medical Device Regulations (EU/Global) is essential
* Knowledge of international/harmonised standards, such as, ISO 13485, ISO 14971, EN 62366
* Relevant degree in management/manufacturing/law or equivalent (desirable)
* Significant experience in:

* generating comprehensive and effective report
* process control improvement projects
* QMS or supplier audits



Other Skills:

* Ability to analyse and interpret complex issues and develop strategies including communication plan to implement change or resolve issues
* Seeks and accepts responsibility to enhance overall performance of the BQMS
* Develops effective collaborative working relationships with customers (internal / external)
* Good communication skills both written and verbal

Salary Guide: £38,000 - £42,000 pa

Location: Harlow, Essex



Sorry that we cannot contact all of you personally, but thanks in advance for your interest.

Please bear in mind that you may not hear from us straight away. Due to the high level of applications we receive every day, we can only respond to applicants whose skills and qualifications are suitable for this position.





Keywords: Quality Assurance & Regulatory Affairs Manager, MDD, ISO 13485
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£38000 - £42000 per annum

Harlow, Essex

8 days ago

Quality Manager - Medical Devices



A Quality Manager with detailed knowledge of medical devices is required by a leading manufacturer that develops chemical technology for the treatment of breathable gases.

The Quality Manager will be responsible for defining and implementing the quality systems and procedures to ensure full compliance to the appropriate standards (ISO13485, 9001).

You will ensure that the finished product are quality controlled to meet specifications and quality standards and will hold operations accountable to deliver high quality products.



Duties & Responsibilities:

* Management of team resource to ensure compliance with the Business Quality Management System (BQMS)
* Hosting of client / 3rd party audits, and managing any non-conformances to satisfactory outcome
* Quality input for NPD/EPD projects
* Conducting staff training in quality system process and good documentation practice
* Monitor/establish root cause analysis of both internal and external non-conformances (quality related)
* Carry out procedural reviews to ensure most effective processes are adopted
* Assist with any Quality related issues and reasonable management requests
* Ensure that the quality team is trained and operates to a high standard and will monitor the team's performance and coach/train where appropriate.





Experience &Knowledge:

* Significant experience gained within a similar industry, working as a Quality Manager
* Degree in relevant scientific / engineering subject
* ISO / MDD training
* Experience in working with multi-disciplinary teams, managing stakeholder expectations
* Strong analytical/problem solving skills
* Good communication skills (written & verbal) & strong presentation skills
* Budgeting, time planning, risk management



Salary Guide: £38,000 - £42,000 pa

Location: Harlow, Essex



Sorry that we cannot contact all of you personally, but thanks in advance for your interest.

Please bear in mind that you may not hear from us straight away. Due to the high level of applications we receive every day, we can only respond to applicants whose skills and qualifications are suitable for this position.
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Pyramid Recruitment Services Ltd

£7.20ph - £7.50ph

Colchester, Essex

16 days ago

We are looking for an organised, enthusiastic and eager Science Technician to join a reputable Secondary School based in Colchester.

The Role:
The successful candidate will be required to help in preparing and delivering orders for practical science lessons, under the guidance and support of the Senior Science Technician. Experience would be an advantage but training will be given.

The Person:
This role requires an all- round team player, hardworking and organised with the ability to react to and work proactively in a timely and ordered fashion.

The Benefits:
- Colchester
- Temporary - ongoing position
- £7.20 - £7.50ph DOE

At Pyramid Recruitment we would love to provide feedback to every applicant that submits an application to our advert, however this is not always achievable due to the high volumes of applications we receive. We kindly ask that if you have not heard back from us within five days of submitting an application to note your application, on this occasion, has not been successful. Pyramid Recruitment Services ltd are acting as an employment agency for the advertised role. The Pyramid team of consultants are all experts in their field of recruitment, these include, but not exclusively, engineering, back office staff, management, sales and temporary staffing solutions. The Pyramid team has a number of years’ experience helping find the right positions for their candidates and the right people for their clients. The consultants are all passionate about delivering a professional and efficient service. With a centrally located office in Colchester we are well equipped to assist with staffing requirements (both temporary and permanent) throughout Essex and Suffolk, across a wide range of sectors.
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