Job Title

MAIN PURPOSECPL Life Sciences are seeking a skilled and experienced quality specialist to oversee the quality activities in related to medical device products with a focus on IVD kits, procedure packs and medical devices supporting the setup and ongoing compliance to ISO13485 and relevant standards and regulations.Duties and ResponsibilitiesQuality Management System:Develop, implement, and maintain the QMS in accordance with applicable standards and regulations.Ensure continuous improvement of the QMS, to processes, procedures relevant and adoption of best practice.Participate & contribute as an auditee & member of the auditee team for external audits.Verification & Validation:Oversee the validation processes involved in the validation of processes, systems and equipment.Analyse, Plan, Specify and Execute verification and validation activities for Products, Packaging and Manufacturing Equipment.Record test failures and deviationsIdentify V&V needs/gaps/opportunities within the businessEngage effectively with key stakeholders (e.g. Engineering, RA etc)Communicate timeously with Quality and Functional leaders.Produce Test reports, supervise approval process.Initiate continuous improvements to the V&V processUtilise eQMS as appropriate.Risk Management:Conduct risk assessments and xFMEA to manage risks and develop mitigation strategies.Oversee the risk management processUtilise eQMS as appropriate.Communicate timeously with Quality and Functional leaders.Communicate residual risks to Quality and Functional leaders.Produce Risk Management documentationSupplier Management:Review and assessment of suppliers, audit where applicable. Perform and complete supplier performance ratings and risk ratings. Issue SCARs (Supplier Corrective Action Requests) as required. Collaborate cross-functionally on Supplier Management processes.Audit Management:Perform internal audits to ensure compliance with the requirements of ISO13485 and applicable standards, regulations and business procedures.Manage as part of team external assessment and audits for ISO13485 and applicable standards, regulations and business procedures.Address audit non-conformances as necessary.COMPETENCY REQUIREMENTSA positive, pro-active can-do attitude.Communicate clearly with strong and adaptable interpersonal skills. Authority to reject product and documentation that does not meet requirements.Be a strong ambassador for Quality culture and mindset.Honest, trustworthy and reliable demonstrate integrity. Time management and ability to prioritise tasks to ensure customer and business needs are met.Flexibility and adaptability to a dynamic and growing businessHave strong attention to detail with the ability to take a holistic view when appropriate. Remain calm and upbeat even in difficult circumstances, always looking for continuous improvement.Self-motivated and able to perform as part of a team, supporting their colleagues when required.Strong verbal and written communication skills. Working knowledge MS Office and Outlook. Preferably with: Knowledge and experience with eQMS/ERP/PLM systemsEssential: Follow Company Quality, Environmental and Health & Safety Procedures.For more information, apply with your updated CV or send a message to jamie.keith@cpl.com