Quality Engineer - £25,000 - £35,000 P/A

Manchester  ‐ Onsite
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Description

Read All ABout It!

A leading global Medical device company specialising in drug delivery products are looking for two like minded, motivated and ambitious Quality Assurance individuals with experience in Medical Devices to join and grow within their busy Quality Assurance department.

Based in Manchester, the key purpose of this role is to follow the regulatory, quality, and technical approach set by the Quality Engineering Manager, on validation and risk management activities within NPI.

Please find the below information detailing your key responsibilities and Key attributes:
- Delivering all Quality Engineering deliverables to time, cost and quality standards to ensure good performance in allocated programmes.
- Reviewing and approving technical risk assessment and programme validation documents to ensure compliance.
- Working with Customers ensuring their quality and regulatory requirements are being met and ensuring that customer requirements are successfully incorporated into programme documentation and the QMS.
- Meeting the requirements by working with Customers and Component Suppliers to define Product/Component Specifications.
- Conducting internal and external (NPI supplier) audits in line with the Quality System to ensure compliance.
- Driving continuous improvement of the validation and risk management processes, ensuring they are effective and efficient.
- Reporting regularly to the Senior Quality Engineer/Product Technical Lead on activities in the allocated programs to ensure alignment to approaches and performance.
- To Interface on areas of specialism with all levels of the organisation, customers and suppliers to ensure full understanding.

You will be / Should have:
- Education to a degree level (or equivalent in science or engineering subject) with a minimum of 3 years experience in validation or a minimum of 3 years experience in MDI, DPI or related products.
- Experience in Validation (Process or Product) and Risk Management Process
- Excellent communication (with all levels of the business, internal and external) and inter-personal skills, enabling the job holder to motivate colleagues, support other areas and influence at a senior level.
- Good working knowledge of all regulations related to the company's products, i.e. ISO 13485, ISO 14971,21 CFR Part 820 regulations and the associated QSR and GMP, EU Council Directives and FDA guidance's.
- Working knowledge of statistical tools, including Design of experiments, R&R and capability indices.

You will be very much wanted if you have:
- Auditing experience
- Experience in Software validation (GAMP 5, 21 CFR part 11, Annex 11) and data management requirements.
- Experience in Facilities validation.

If you have all of this, then this is the job for you.

Pick up the phone and ring or alternatively, message me on LinkedIn under the name Marvin Trenchfield.

Please note: This role requires EU membership
Start date
10/2015
From
Real Staffing
Published at
03.10.2015
Project ID:
993830
Contract type
Permanent
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