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| Job Location | Bridgend Industrial Estate, Bridgend |
| Education | Not Mentioned |
| Salary | 42,000 - 45,000 per annum |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent , full-time |
Jennifer Griffiths Recruitment are looking for a Design Quality Project Engineer for a Client in the Bridgend area.Key Responsibilities* Work closely with internal groups (Marketing, Sales, Product Development, Regulatory and Management) and external groups (Clinicians, Distributors and Regulatory agencies) to assess and potentially redefine or clarify system level requirements, Use-Conditionsand risks for the development of the devices.* Project management of Special Applications development projects.* Creation of User Requirement Specifications, Design/Installation/Operational/Performance Qualification protocols and reports for validation and/or trial purposes.* Provide technical assistance and resolution when engineering problems are encountered before, during and after construction culminating in successful Factory Acceptance Tests.* Preparation of technical documents such as component specifications, risk management reports and technical reports for incorporation into product technical files.* Define and manage strategies to evaluate performance of developmental parts, assemblies, or systems under simulated operating conditions.Experience/SkillsEssential* A minimum of 5 years work experience in the medical device industry.* Knowledge of regulations such as GLP, GMP, ISO 13485 and ISO 14971, as well as other international regulatory requirements.* Experience in related areas, such as R&D or Manufacturing, may also be applicable if experience includes work responsibilities listed above.* The ability to work alone and unsupervised or as part of a closely integrated project team.* Technical competency both analytical and practical.* Excellent interpersonal skills.Desired* Knowledge of FDA requirements 21 cfr 820 and 21 CFR 11.* Knowledge of EU GMP Annex 11, 21 CFRPart11, GAMP 5 and associated computerised system validation within the pharmaceutical environment.* Knowledge of EU GMP Annex 15 for process validation.QualificationsBachelors degree or HND qualification in science or engineering subject.The hours of work are Flexible between 8am to 5pm/Monday to Friday/37.5 hours a week.The salary depends on experience - up to £45k a year.
Keyskills :
GLPProject ManagementQuality ControlGAMPISO Procedures