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Quality Systems Specialist Job Type: Full-time Location: Cardiff Salary: Up to 38,000 We are seeking a Quality Systems Engineer to support the management and improvement of quality systems processes for our client based in Cardiff. They are looking for someone with a minimum of 3 years' experience in a QA/QS environment, ideally within the medical device or pharmaceutical industry. Day to Day of the role: Implement and monitor policies and procedures to ensure compliance with regulatory bodies in areas such as CAPA, Complaint, Post Market Surveillance, and NCR. Provide advice on established procedures and regulatory requirements including ISO13485, MDD 93/42/EEC, Medical Device Regulation (EU) 2017/745, and 21 CFR Part 820. Offer effective solutions to design and manufacturing teams to ensure products meet regulatory standards. Generate reports for management to monitor system performance. Review and authorise Quality Management System documentation and processes for compliance. Identify and implement changes to the Quality System to increase efficiency while maintaining compliance. Conduct training to maintain company-wide awareness of Quality System requirements. Perform internal and inter-company Quality System Audits. Work in accordance with Company Quality Standards, GDP, and GMP. Deputise for the Senior Quality Systems Engineer as required. Required Skills & Qualifications: A level or equivalent in a Science/Engineering/Quality orientated qualification. Minimum of 3 years' experience in a QA/QS environment within the medical device or pharmaceutical industry. Knowledge of ISO13485:2003, MDD 93/42/EEC, and FDA QSR Part 820. Proficient in MS Word, Excel, and MRP systems. Familiarity with GMP and audit processes. Ability to work independently with minimal supervision. Excellent interpersonal skills and the ability to communicate effectively in English, both written and orally. Strong record/documentation skills. Demonstrates integrity, customer focus, accountability, and teamwork. Benefits: 25 days annual leave plus bank holidays 10% annual bonus non-contributory 10% pension scheme To apply for the Quality Systems Engineer position, please click the link below.
Quality Assurance Specialist Job Type: Full-time Location: Cardiff Salary: Up to 38,000 We are seeking a Quality Systems Engineer to support the management and improvement of quality systems processes for our client based in Cardiff. They are looking for someone with a minimum of 3 years' experience in a QA/QS environment, ideally within the medical device or pharmaceutical industry. Day to Day of the role: Implement and monitor policies and procedures to ensure compliance with regulatory bodies in areas such as CAPA, Complaint, Post Market Surveillance, and NCR. Provide advice on established procedures and regulatory requirements including ISO13485, MDD 93/42/EEC, Medical Device Regulation (EU) 2017/745, and 21 CFR Part 820. Offer effective solutions to design and manufacturing teams to ensure products meet regulatory standards. Generate reports for management to monitor system performance. Review and authorise Quality Management System documentation and processes for compliance. Identify and implement changes to the Quality System to increase efficiency while maintaining compliance. Conduct training to maintain company-wide awareness of Quality System requirements. Perform internal and inter-company Quality System Audits. Work in accordance with Company Quality Standards, GDP, and GMP. Deputise for the Senior Quality Systems Engineer as required. Required Skills & Qualifications: A level or equivalent in a Science/Engineering/Quality orientated qualification. Minimum of 3 years' experience in a QA/QS environment within the medical device or pharmaceutical industry. Knowledge of ISO13485:2003, MDD 93/42/EEC, and FDA QSR Part 820. Proficient in MS Word, Excel, and MRP systems. Familiarity with GMP and audit processes. Ability to work independently with minimal supervision. Excellent interpersonal skills and the ability to communicate effectively in English, both written and orally. Strong record/documentation skills. Demonstrates integrity, customer focus, accountability, and teamwork. Benefits: 25 days annual leave plus bank holidays 10% annual bonus non-contributory 10% pension scheme To apply for the Quality Systems Engineer position, please click the link below.
Quality Assurance Engineer Job Type: Full-time Location: Cardiff Salary: Up to 38,000 We are seeking a Quality Systems Engineer to support the management and improvement of quality systems processes for our client based in Cardiff. They are looking for someone with a minimum of 3 years' experience in a QA/QS environment, ideally within the medical device or pharmaceutical industry. Day to Day of the role: Implement and monitor policies and procedures to ensure compliance with regulatory bodies in areas such as CAPA, Complaint, Post Market Surveillance, and NCR. Provide advice on established procedures and regulatory requirements including ISO13485, MDD 93/42/EEC, Medical Device Regulation (EU) 2017/745, and 21 CFR Part 820. Offer effective solutions to design and manufacturing teams to ensure products meet regulatory standards. Generate reports for management to monitor system performance. Review and authorise Quality Management System documentation and processes for compliance. Identify and implement changes to the Quality System to increase efficiency while maintaining compliance. Conduct training to maintain company-wide awareness of Quality System requirements. Perform internal and inter-company Quality System Audits. Work in accordance with Company Quality Standards, GDP, and GMP. Deputise for the Senior Quality Systems Engineer as required. Required Skills & Qualifications: A level or equivalent in a Science/Engineering/Quality orientated qualification. Minimum of 3 years' experience in a QA/QS environment within the medical device or pharmaceutical industry. Knowledge of ISO13485:2003, MDD 93/42/EEC, and FDA QSR Part 820. Proficient in MS Word, Excel, and MRP systems. Familiarity with GMP and audit processes. Ability to work independently with minimal supervision. Excellent interpersonal skills and the ability to communicate effectively in English, both written and orally. Strong record/documentation skills. Demonstrates integrity, customer focus, accountability, and teamwork. Benefits: 25 days annual leave plus bank holidays 10% annual bonus non-contributory 10% pension scheme To apply for the Quality Systems Engineer position, please click the link below.
Are you an experienced CAD Designer, who is looking to work in a Product Development Team taking projects right through the Development Lifecycle. My client is looking for someone who is able to join a multi-discipline team, and the responsibilities will be: Ensure product architecture and compatibility is examined during product development Apply mechanical designs to create, review and approve both 2D and 3D CAD models Participate in continuous improvement projects Assist Engineering Team with root cause analysis Liaise with other departments to ensure complete transition of new products from design to architecture and test The ideal candidate will: Be qualified to degree level in relevant engineering discipline Experience of working with materials such as sheet metal, foam, plastics and soft goods/fabrics Competent in CAD and associated tools Knowledge of control systems For this, you will receive: Salary of up to £48,000 Flexible working hours, along with hybrid working Training on latest technologies For more information, please contact Stuart on or By applying to this advert you are giving CPS Group (UK) Ltd authority to hold and process your data for this specific role and any other roles we may deem suitable to you over time. We will not pass your data to any third party without your verbal or written permission to do so. All incoming and outgoing calls are recorded for training and compliance purposes. CPS Group (UK) Ltd is acting as an Employment Agency in relation to this vacancy. Our new privacy policy can be found here https://company-policies