Quality Engineer/Quality Improvement/New equipment Validation

Highland  ‐ Onsite
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Keywords

Description

Role: Quality Engineer/Quality Improvement/New Equipment Validation

Location: Inverness, Scotland

Length: 6 month rolling Contract

My client is a leader in the medical device industry. They are currently looking for a Quality engineer to provide Quality Engineering support for several quality improvement initiatives, including new equipment validation. 

Responsibilities: 
Support quality improvement initiatives such as process and product characterizations that lead to continuous/cost improvements. 
Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs. 
Conduct benchmarking to develop more effective methods for improving quality 
Support the implementation of electronic batch records and automated Statistical Process Control software 
Review/analyze whether current product and processes are in compliance to standards such as the QSRs, ISO 13485, etc. 
Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes 
Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. 
Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk. 
Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support. 
Develop, interpret and implement standard and non-standard sampling plans 
Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management. 
To prepare and issue Validation Master Plans, Protocols, Summary Reports and other documentation associated with equipment and process validation of, as appropriate for each validation exercise. 
To ensure all validation activities and documents are authorised and appropriate compliance approval is gained 
To ensure that all validation activities are carried out and reported in a timely manner 
Keep management informed of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health & safety, company operations, and/or the environment 

Skills/Knowledge: 

Required: 
A minimum of a Bachelors Degree, preferably in Engineering or related technical field. Generally requires 4-6 years related experience. 
Knowledge on Statistical Process Control, Control Plans and FMEAs is required. 
This position will require relevant experience working in manufacturing/operations. 
In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required. 
Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc. 
Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making. 
Previous experience working in a regulated industry, minimum of two years working in an FDA regulated environment. 
Change Management 
In depth knowledge of 21 CFR 820, 21 CFR part11, ISO 13485:2003 and European regulations associated with the medical device industry 
In depth knowledge of GAMP 5 and SDLC process methodologies. 

Start date
ASAP TO NOTICE
Duration
6 months rolling
From
Larson Group
Published at
26.07.2014
Project ID:
748790
Contract type
Freelance
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