Heather Deagle is recruiting for a Quality Engineer to work for a medical device company that manufacture a prestigious range of neuro and orthopaedic products. The Quality Engineer will be working at their state of the art site in Lancashire on a 12 month contract basis. This client is offering an opportunity to be involved in pioneering projects that are truly making a difference to peoples lives everyday, worldwide.
The primary responsibility of the Quality Engineer will be to plan and direct all of the site validation activities, provide daily support overall and to maintain a ready state of validation compliance
Further responsibilities include:
• Supporting all validation activities on-site - product/process, test method, CSV, including Resolution of Problems encountered during validation
• Completing all annual validation review assessments
• Maintaining Site validation master plan
• Supporting validation activities through reviewing and approving all validation documents
• Championing compliance to applicable regulations and standards.
• Ensuring all validation procedures meet the requirements of all applicable regulations, standards and global procedures
• Active leadership in site validation activities, including lead of Site validation steering group
• Leading risk mitigation activities associated with product/process validations
• Drive overall Dashboard performance for Operations.
As a Quality Engineer, you will have the following qualifications, skills and experience:
• A degree in scientific / Quality / Engineering discipline.
• Experience in a quality, technical or manufacturing role in a regulated industry.
• Well-developed organisational skills with an ability to work independently.
• Working knowledge of ISO9001, ISO13485 and FDA Quality System Regulations an advantage.
• Previous Experience of changing validation systems on regulated sites
• In depth knowledge of Good Manufacturing Practice.
• In depth knowledge of Current Validation Practice
• In depth knowledge of quality systems and techniques including ISO 13485 and FDA QSRs.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Technical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been short listed for the next stage of the recruitment campaign. Entitlement to work
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 14th March 2018
- Expires: 11th April 2018
- Reference: TC41529