Medical Device QA Manager jobs

Closing Date for Application:

Role:

This role's purpose is to ensure quality compliance for Polypipe Building Services, Cistermiser and Keraflo.

Key Responsibilities:

Cistermiser/Keraflo migration:

• Ensure compliance to the Quality Plan for Cistermiser and Keraflo products.
• Internal Quality Plans compliance to support effective inhouse product assembly and testing controls/processes.
• Ensure compliance to external Quality Plan for Cistermiser and Keraflo products
• External Quality Plans compliance to support third party product manufacture and testing controls/processes.
• Translate all product drawings to create Product Information Sheets (PIS)
• Utilisation of Faro Scanner to reverse engineer component parts to support with creation and/or validation of product drawings.
• Migrate product drawing information into current Product Information Sheets for Production and Assembly.
• Create and train out all required component/product test methods.
• Develop test methods in relation to production control, product assembly and quality assurance (type testing) to ensure effective quality controls of functioning products.

Quality Compliance:

• WRAS approvals for site
• Ensure WRAS certification compliance for all required products and components is maintained.
• BSI and BBA Approvals for site
• Oversee BSI and BBA certification for all required products is maintained.
• Oversee annual submissions to BSI are delivered on time to BSI.
• Ownership of base quality information.
• PAS2000 compliance.
• Internal IMS audits.
• Support with completion of internal IMS audits inline with audit plan.
• External IMS audits (BSI and BBA)
• Support with leading/hosting of all external audits relating to quality aspects.
• Support and represent quality for all key strategic projects.
• Support with Continuous Improvement maintenance and updating of Electronic Management System.
• Provide guidance on all QA/QC product and material related matters.
• Ensure compliance for site wide calibration of Quality gauges and maintain records, ensuring calibrations records are kept up to date.
• Promote continual improvement through the use of processes and procedures whilst adopting and maintaining a long-term quality culture.

Skills and experience required:

• Ability to be a team player
• Ability to coordinate and focus supporting team where applicable in order to realise objectives.
• Ability to analyse processes, find and implement improvements including the design and documentation of new systems and processes as well as training of personnel in new and current working methods.
• In depth knowledge of applicable product and material standards
• Ability to read and interpret Product Information Sheets and product drawings (including fabrication designs), certificates of conformity and Material Data Sheets
• Competent in all aspects of product and material testing within scope applicable to the Polypipe products
• Good working knowledge of Quality systems
• Competent in accurately recording results of all evaluations and audits in a clear legible manner consistent with the requirements of the respective standards.
• Competent in carrying out Systems and Product audits inline with consistent with the requirements of the respective standards.
• Computer literate – working knowledge of ERP, Mattec, and Microsoft 365
• Excellent communication skills
• Ability to understand pertinent legislation and relate to company business/processes.
• Competent in all Test Methods applicable to Quality

Working Hours and benefits:

• Monday - Friday onsite (37.5 hours per week) with flexible start and finish times available
• 25 days holiday entitlement with Holiday Purchase Scheme opportunity
• Save as you earn Sharesave Scheme
• Cycle to work scheme
• Contributory pension scheme
• Life assurance
• Free flu vouchers
• Various health & wellbeing initiatives including complimentary occupational health on-site physiotherapy and counselling services
• Staff discount on all Genuit Group products
• Free on-site parking

Here at the Genuit Group we recognise and develop the contribution our people make to the Group’s success and are committed to attracting talent from the widest pool. We have a role to play in making the built environment more sustainable, building a low carbon business ourselves as well as delivering sustainable solutions at scale.