Internal & Supplier Quality Auditor - Southern

0 - Quality
Ref: 132 Date Posted: Monday 20 Nov 2017

Our clients Manufacturing Business Centre plays a key role in the development and manufacture of new, sophisticated medical and industrial products. Working with colleagues in Europe, the USA and Japan, our multi-disciplinary team of R&D engineers is fully equipped with the latest computer-aided design and modelling technologies, to enable them to develop medical workstations and fluid management products & accessories, and industrial Remote Visual Inspection devices.

Producing world class products in terms of Quality, Cost and Delivery isn't just desirable, it's essential. Therefore, in today's fast moving, ever changing world, we continue to invest in both our people and the latest equipment and processes to remain at the forefront in manufacturing technology.

Your Responsibilities:

Define, manage and lead an internal/supplier audit programme for the quality management system and complete audits according to the plan
Ensure actions as a consequence of audits are completed within specified timescales
Ensure continued regulatory compliance to international regulations and standards
Provide internal auditor training
Ensure supplier audit file are complete including ISO certificates and other relevant documents.
Provide and present regular detailed management reports . 
Lead and Support 3rd party audits (MDSAP)
Represent the company during external audits e.g. FDA, Notified Body

Your Qualifications:

Educated to a higher technical qualification in an engineering, science and/or business related subject e.g. Bachelor degree or equivalent.
The position holder must be a trained auditor, preferably through an IRCA recognised course or equivalent to MDSAP and/or ISO 9001:2015 and ISO 13485:2016.
Must be an excellent communicator both verbal a written. Must have expert knowledge of QMS standards/requirements and quality engineering.
Experience of auditing and assessing to multiple standards and regulations with a particular emphasis on quality management. Able to work under minimal supervision and make decisions for work priorities.
Minimum of 10 years’ experience within a Quality Assurance/Regulatory Affairs role. 

Your Competencies:

The interview will be competence based and the following competencies will be assessed:

·         Continuous improvement

·         Delivering results

·         Problem solving, creativity& decision making

·         Project management

Additional Information: 

Location: Essex - Southend on Sea

Salary: Dependent on experience +Benefits 


- Defined-contribution Pension Scheme
- Free Life Assurance
- Private Medical Insurance
- Free Annual Health Check
- On-site Day Nursery
- Subsidised Staff Restaurant

Specialists in consultancy

At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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