Description
Validation Quality Engineer - Medical Devices - Blackpool £26. Month Contract
Quality Engineer, Pharmaceutical, Medical Devices, Validation,medical devices
Summary of position
Part of the Quality team reporting into the Quality Manager, QE & QC. The Validation Engineer's responsibilities are critical to plan and direct all of the site validation activities, provide daily support overall and to maintain a ready state of validation compliance. Due to the Legacy products on-site there is an element of remediation activities that is on-going. This position requires an in-depth knowledge of both Quality, Compliance and Validation, in alignment with ISO 9000, ISO13485, FDA QSRs and the Medical Devices Directive.
Duties & Responsibilities (leadership, people development, planning and execution)
. Support all validation activities on-site - product/process, test method, CSV, including Resolution of Problems encountered during validation
. Complete all annual validation review assessments
. Maintain Site validation master plan
. Supporting validation activities through reviewing and approving all validation documents
. Champion compliance to applicable regulations and standards.
. Ensure all validation procedures meet the requirements of all applicable regulations, standards and global procedures
. Supports the development of quality strategies related to the transfer of products, materials and components.
. Active leadership in site validation activities, including lead of Site validation steering group
. Lead risk mitigation activities associated with product/process validations
. Drive overall Dashboard performance for Operations.
Quality and Compliance Related Responsibilities
. Ensures that all activities are carried out in compliance with all regulations and laws governing business and quality operations.
. Responsible for ensuring compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance. Job Specific Competencies
. 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.
. Knowledge of Quality toolbox including FMEA, Mind-Map, Root cause investigations, Lean and Six Sigma tools & techniques.
. Computer literate.
GLP Competencies
. Ability to carry out structured problem solving and Credo based decision making.
. Ability to communicate effectively at all levels across the business.
. Ability to build productive relationships at all levels of the organization.
. Takes a determined approach to problem solving and to make informed decisions.
. Ability to make complex issues simple.
. Ability to manage and adapt to changes effectively.
. Identifies ways of doing things better and faster.
. Ability to listen effectively and remain open to other's ideas.
. Ability to express opinions and ideas, verbally and in writing.
Education
. Minimum of degree in scientific/Quality/Engineering discipline.
Experience
. Minimum of 5 years 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
Personal Attributes
. Detail conscious
. Excellent time-management
. Good interpersonal skills
. Ability to Train Personnel
. Focus on achievement and delivery of results
. Versatile - readily grasps technical detail outside own speciality
. Well organised, can cope with a number of competing projects and activities
.
Specific Technical Skills
Essential
. Must have experience of working to International Quality Standards such as FDA and ISO.
. Use of Microsoft Office suite including Word and Excel for generating reports.
. Good written and verbal communication skills. Desirable
. Use of Microsoft Office suite including Project.
. Lean Manufacturing application
Larson Resource Group Limited is registered in England & Wales with a company number . Registered office address is Windsor House Cornwall Road Harrogate HG1 2PW. Our VAT number is . Larson Resource Group Limited trades as an Employment Agency when placing permanent candidates and as an Employment Business when placing Contractors (under the Conduct of Employment Agencies and Employment and Business Regulations 2003) In accordance with these regulations you should have received a copy of our Client Terms of Business. If you have not received a copy please contact a member of staff immediately. All discounted rates quoted are only valid providing all other terms are met in accordance with our standard Client Terms of Business.