Adecco LifeSciences are proud to be partnering with a world leading independent developer and manufacture within the Medical Devices industry. A brilliant opportunity for a Group Quality Process Improvement Engineer to join a global organisation , who pride themselves on being able to create an engaging and challenging place of work, developing individuals to the best of their abilities, and providing the correct environment to foster innovation, growth, and meaningful work.
To provide support within the Group Quality Process Team to successfully deliver Quality and Operational strategy to deliver corporate goals and objectives.
Responsible and accountable for successful project planning and execution. Scheduling, planning, and resourcing business interactions.
Responsibilities to ensure meeting agreed requirements accurately and on time, maintaining compliance to quality. Works collaboratively with other departments across the business within Operations, Quality and IS to provide support and guidance for the organisation's Continuous Improvement initiatives and provide leadership for new system development, implementation, procedures, and any related quality activity, while striving to emulate the best practices. Support across the organisation to ensure quality systems comply with the medical device requirements of cGMP, MDSAP applicable regulations and the Medical Device Regulation (MDR). Ensuring the development and improvement of the quality management system across the organisation.
Lead and support the maintenance and improvement of the Label Management system to comply with the requirements of ISO 13485, MDR and MDSAP regulations through the development, implementation, maintenance, and improvement of a compliance system. Including but not limited to.
Liaise with the supplier on the system design and development to ensure a configured process is achieved to meet applicable business requirements
Develop, execute, and maintain supporting documentation, including SOP's Change Controls, Validation documentation and activities to support the software life cycle
Work collaboratively with the project team to ensure that specifications meet Implementation requirements
Anticipate problems; actively work to minimise any impact on the business and strive for timely problem resolutions.
Provide guidance and support to the maintenance and improvement of the quality management system to comply with the requirements of ISO 13485, MDR and MDSAP regulations through the development, implementation, maintenance, and improvement of a standardised electronic Quality Management System. Including but not limited to.
Design and development of configured processes to meet applicable requirements
Develop, execute, and maintain supporting documentation, including SOPs, Change Control, Validation documentation and activities to support the software life cycle
Coordinate and plan the implementation activities with sites in accordance with the company strategy
Assess and implement ongoing eQMS change requests and maintain associated documentation
Provide guidance and support group-wide to the organisation on what is required in validation master plans and related protocols and reports. Including but not limited to.
Develops, reviews, and approves master validation plans, strategies, protocols, and reports
Establishes and evaluates the adequacy of validation methods for new or modified systems changes
Reviews and approves validation protocols and reports in conjunction with the supporting data and documentation for adequacy and completeness
Reviews and approves risk analysis for adequacy; able to evaluate changes to a design and associated risk documents.
Perform other related duties as assigned
Support the successful execution and implementation of applicable Quality strategies, including supporting, reviewing or, where identified leading standardised group procedures/processes
Support and maintain a group document control process for group procedures and records
Support site audit schedules for supplier and external audits as required
BS or equivalent in scientific discipline or the abilities that are typically acquired through a minimum of 2 years' experience in medical device or pharmaceutical industries.
Must be proficient in the knowledge of applicable Quality System Regulations and ISO quality requirements (Medical Device experience preferred)
Must have a fundamental understanding of a quality management system and its development, documentation, and implementation
Must have working knowledge of Software Validation requirements in accordance with GAMP, 21 CFR Part 11 and Eudralex Volume 4 Annex 11
Able to demonstrate achievement and continual improvement against key performance targets and Quality Objectives
Ability to develop and implement quality improvement initiatives, including tracking, analysing, and reporting on progress and effectiveness
Ability to manage own time effectively, priorities tasks, deliver to critical deadlines and support multiple projects
Ability to manage multiple projects
Able to work autonomously and as part of a multi-disciplinary team
Proficient in spreadsheets and word processor applications
Good written and oral communication/presentation skills are required, for example to ensure effective communication with staff, peer groups, etc. across organisation
Computer literate - knowledge of Word, PowerPoint and Excel an advantage - in order to produce procedures, analyse data etc. effectively
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