Job Details  
Advertiser: Incite Solutions Ltd

 
Job Title: Medical QA Engineer -The Right Time TO Join!
Location:Nottingham
Rate:£35K.00 to £50K.00 Per Year
Description: Senior QA Engineer ( Medical)

Location-Nottingham

Salary- 50,000

Benefits Package

*26 days holiday (additional 4days available to buy)

*Medical care

*10% pension scheme

*Life insurance (10 times amount of salary)

*Gym membership

*Cycle to work scheme and more!

My client is based in Nottingham and are working in the medical RnD sector, they have approx. 10 people on site, but are rapidly growing after being backed by a major player in the multi-national medical sector. After doubling in size last year, they are on track to do the same this year. Their growth plans include the globalisation of their products, already being distributed across 1000 sites in parts of Europe, Asia and North America they have plans to make this available worldwide.

In line with the leaps forward they are making as a company, they need a Senior QA Engineer to help with the globalisation of their one of a kind medical system. You should be experienced in regulatory submission and design control for the medical sector or other highly regulated sector.

The product you will be overseeing includes elements in wireless electronic transducers, ECG electrode patch technology and wireless communications/ interfaces.

What will you be doing?

Responsible for ensuring 100 percent Quality Management System compliance in accordance with documented procedures for all aspects of the business.

Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency.

Supports continuous product and process improvement through detailed failure analysis for non-conformance, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).

Ensures process compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.

Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.

Where required undertake internal audits in accordance with processes to ensure compliance to FDA CFR 21 820, ISO13485 : 2016 and MDSAP.

Where required work with subcontract manufactures to ensure all quality, requirements have been met during the manufacturing process and before product is released to market.


Your Skill Set

Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820, ISO13485 : 2016 and MDSAP.

Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing /production process control methodologies, and servicing in a medical device environment.

Significant Multi-Modality Sites: Proven years Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry

Small and Simple Sites: Some years Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry

Demonstrated experience using word processing, spreadsheet, and presentation software

Demonstrated understanding of continuous quality / process improvement tools: (As defined by the local site, e.g. DMIAC, SPC, Lean SS, 5S,)


This is a unique chance to be involved in revolutionary medical technology on a global scale, you get an excellent package and the team you are working with offer a relaxed yet professional working environment.

Some global and UK travel may be required so you must be prepared to do this when required.

Interviews are being held next week or on receipt of suitable CV’s, please contact me, Imogen, on 01174280600 or email imogen@isluk.co.uk


ISL (Incite Solutions Ltd) is acting as an Employment Agency in relation to this vacancy.
Skills Required: Medical QA Engineer -The Right Time TO Join!
Job Type: Permanent
Start Date:
Contact: Imogen Moody Contact E-mail: Click
Contact Tel: 0117 4280600 Contact Fax:
Reference: BBBH22652 Added: 09-05-2018
  IMPORTANT: For jobs based in the UK it is unlawful to employ a person who does not have permission to live and work in the UK. Please ensure you have this permission before applying, unless the advert states otherwise.
 
 
 
 
 
 
 
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