Cardiff, Wales, United Kingdom Hybrid / WFH Options
Gyrus Medical Ltd An ATL Technology Company
applicant will: Implement and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: CorrectiveandPreventiveAction (CAPA), Complaint, Post Market Surveillance and Non-conformance Report (NCR). Provision of advice according to established procedures relating to CAPA, Complaint, Post Market Surveillance andmore »
and working to support and track actions that are to be taken. •Support quality related investigations, assist in the development and approval of effective CAPA in order to resolve product, audit and customer issues. •Support effective pre-audit preparation and post audit follow up of customer audits and regulatory inspections. more »
tool for improvement as well as compliance and challenges existing practice where appropriate. Supports and process NC and/or CorrectiveandPreventiveAction (CAPA) to address operational issues within the PPA areas. Supports with project related document and technical review. Generation and monitoring of data streams and analysis to … functional teams whilst ensuring that deadlines are met. Competent auditor. Experience in hosting or acting as SME during external regulatory audits. Strong knowledge and experience of CAPAand NC for medical devices A practical working knowledge of implementation of change control, and of all aspects of the process and equipment more »
development and troubleshooting including reviewing protocols, study plans, SOPs or reports as required. 4. You will document and complete any quality documentation (quality issue, CAPA, deviation, change control) as appropriate and within required time frames. ROLE REQUIREMENTS: To be successful in your application to this exciting opportunity as the Study more »
Control (QC) review. Construction and submission of result tables/reports. Manage quality investigations and/or issue resolution; CorrectiveAction/Preventative Action (CAPA) system management. Ensure all data is archived in accordance with company SOPs and regulatory requirements. Responsible for financial monitoring for all assigned studies, ensuring all more »
processes to address constraints.Lead the execution of common IT processes across Data Platforms solutions and services. (ie. Access Roster Reviews, Periodic Reviews and other CAPA activities.)Represent the team in vendor governance meetings and ensure compliance with change management and ITSM processes.Minimum Qualification (education, experience and/or training, required more »
Engineering phase of a project within the orthopaedic field where the manufacturing process is characterised by high process complexity, risk, and innovation; this includes CAPA projects as well as NPI projects. Drive innovation under initiative within the orthopaedics field's constraints. Identify new technologies which can bring innovation to support … the Supplier Quality Team Promote the sharing of knowledge about process engineering applied to orthopaedic technologies. Support the company's Correctiveandpreventive Actions (CAPA) activities and act as a subject matter expert for the Process Engineering tasks within the assigned CAPA project and ensure that process and timeline requirements … for CAPA are met by Corin’s Standard Operating Procedures (SOP’s) and in support of Corin’s Global Objectives. Support for internal audits. more »
Job Title: Senior Quality Evaluator - English plus ( either French, Spanish or German - B2 ) Belfast Onsite Job Description: The role of Senior Quality Evaluator is to coach team members while enforcing policies and driving quality performance, while balancing the need for more »
expectations. Daily interaction with VWR who manage site consumables and reagents via in-plant personnel. Responsibilities: Work closely with the labs to lead Deviations, CAPA’s, and Change Controls through to on-time completion. Participate in lab improvement projects. To ensure appropriate standards of cGMP, Housekeeping, Health, Safety and Environment … delivery from across the Liverpool sites to the labs in a timely manner. Keep oversight of and facilitate on time completion of DR’s, CAPA’s, Change Controls and SOP Updates Monthly and annual report writing for EM, Bioburdens and Endotoxin results, including annual product review. To collate data relating … to site and organisational changes that will impact the efficient running of the laboratories. Manage the completion of DR’s, CAPA’s, Change Controls and SOP updates working closely with the QC labs. Attendance at and presentation at DRB. CAPEX project submissions and management. Invalid reporting. Maintenance of QC metrics. more »
Bristol, Avon, South West, United Kingdom Hybrid / WFH Options
Smartbox Assistive Technology
Compliance and Quality Assurance Manager Our trailblazing global AAC (Augmentative and Alternative Communication) company, is on the lookout for an exceptional Compliance and Quality Assurance Manager to join our product development team and report to the Head of Hardware. At more »
internal/3rd party audit methods Experience of managing quality issues across a multi-site organisation Demonstrable experience in resolution of customer complaints andCAPA Experience in conducting audit and managing audit schedules (internal and third party) Demonstrable experience in writing policies and procedures and managing document control systems Experience more »
and working to support and track actions that are to be taken. Support quality related investigations, assist in the development and approval of effective CAPA in order to resolve product, audit and customer issues. Support effective pre-audit preparation, management and post audit follow up of customer audits and regulatory more »
Bristol, England, United Kingdom Hybrid / WFH Options
Smartbox Assistive Technology
Compliance and Quality Assurance Manager Our trailblazing global AAC (Augmentative and Alternative Communication) company, is on the lookout for an exceptional Compliance and Quality Assurance Manager to join our product development team and report to the Head of Hardware. At more »
and implement continuous improvement activities across all areas related to countries and regions PV activities to optimise quality and productivity, including process improvement andCAPA management and implementation Work closely with Global Process Owners to ensure local implementation of global pharmacovigilance procedures For assigned countries, primary GPV point of contact … develop holistic understanding of situations and requirements, in order to deliver solutions that work across stakeholders Strong collaborator and problem solver Quality mindset inc CAPA management Fluent in English Computer literate Additional Information Personal Attributes Required: Strong communication skills, including across geographies and functions Strong analytical/problem-solving skills more »
and Regulatory requirements and to ensure that proprietary information is protected at all times. Responsible for the recording and investigation of Non conformances andCAPA using root cause analysis tools where appropriate and regular reporting on NCs and CAPAs. Responsible for NC andCAPA process management and regular reporting of … RA Manager & RP in ensuring that a quality management system (QMS) is implemented and maintained including quality risk management, documentation management, non-conformance andCAPA, change management, deviation processes, internal and supplier approval and audits as well as measurement of performance indicators and management review Take ownership for assigned projects more »
Cardiff, South Glamorgan, Wales, United Kingdom Hybrid / WFH Options
Gyrus Medical Ltd An ATL Technology Company
applicant will: Implement and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: CorrectiveandPreventiveAction (CAPA), Complaint, Post Market Surveillance and Non-conformance Report (NCR). Provision of advice according to established procedures relating to CAPA, Complaint, Post Market Surveillance andmore »
Slough, Berkshire, South East, United Kingdom Hybrid / WFH Options
Orion Electrotech Professional Engineering
their Improvement Culture, using your insight and analysis from performing audits as to were improvements can be implemented Play an instrumental part in their CAPA division within their Quality Team, this means that you will take the reigns on investigating non-conformances and collaborate on CAPA objectives. Working with the … client) Hands on knowledge of IS0 3485 i.e. you have worked in medical device manufacturing in a quality engineering role. Solid understanding of running CAPA driven activities, therefore you will be able to provide examples of where you have worked on CAPA driven initiatives within medical device manufacturing. Thank you more »
implementation of appropriate countermeasure actions. * Lead and support structured problem solving teams to bring customer, internal & supplier quality issues to conclusion. * Compilation of quality CAPA (8D) reports on non-conforming products or information received from customer complaints/warranty product reviews, internal quality and supplier quality concerns. * Maintenance of all more »
customer, regulatory, internal & compliance audits. Analysis of quality data & generation of quality reports. Support final product disposition & control of non-conforming material. Support the CAPA process, including deviations & customer compliant investigations, ensuring robust root cause analysis & appropriate corrective actions are implemented. Coaching and training of production and technical personnel on more »
drafting of new procedures to enhance the companies QMS. · Support with assessment of deviation event investigations. · Support closure to plan of Change Controls andCAPA actions. · Issue, review and approval of GMP batch manufacturing records to support certification and release. · Assist in performance of internal self-inspection audits. · Support the more »
that an escape occurs, the engineer also makes sure that the proper root cause investigation is conducted and that planned, tested, and implemented correctiveandpreventiveaction is taken. Experience/Skills: Extensive knowledge and experience with statutory regulations for global market products, particularly electrical/electronic systems. Ability to more »
SAP, Quality Systems and H&S reporting tools. Proficient in the use of Root Cause Analysis Tools. Actively supports Non Conformance investigations and resultant CAPA(s). Coaches IFM Operations, Engineering, Technicians, Cleaning and other staff in ensuring QHSE requirements are met. Reports all non conformances to Senior Management to … and experience of QHSE continuous improvement Experience of Management and/or Supervision of staff Knowledge and experience of non compliance investigations, RCAs & respective CAPA plans Excellent Report/presentation writing skills Strong interpersonal and analytical skills Knowledge of cGMP regulations- desirable Experience of working in the Pharmaceutical or other more »
requirements. Work Closely with Mixing and Production in the development of IPC's for new products. Support all site functions with technical investigations andCAPA actions linked to process/formulation non-conformances. Required Experience Qualified to at least BSc or equivalent in Chemistry or a similar technical discipline Good more »
Bishop's Stortford, Hertfordshire, South East, United Kingdom Hybrid / WFH Options
HR GO Recruitment - Bishop's Stortford
quality audits to meet ISO, UK, European and worldwide regulatory requirements. Facilitate quality improvement initiatives. Analyse data for management reviews and non-conformances. Conduct CAPAand non-conformance investigations. Review customer complaints and maintain incident reporting. Meet LSAS objectives and targets. Core Competencies: Experience with BS EN ISO 13485 and … manufacturing environment. Internal and external quality auditing experience to ISO 13485. Passion for quality excellence. Previous quality assurance experience, including QMS documentation. Knowledge of CAPAand root cause analysis tools. Practical problem-solving approach. Understanding of ISO 14971 quality risk management principles. Self-motivated and team-oriented. Ability to manage more »