MAIN PURPOSE
CPL 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 Responsibilities
Quality 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 deviations
* Identify V&V needs/gaps/opportunities within the business
* Engage 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 process
* Utilise eQMS as appropriate.
Risk Management:
* Conduct risk assessments and xFMEA to manage risks and develop mitigation strategies.
* Oversee the risk management process
* Utilise eQMS as appropriate.
* Communicate timeously with Quality and Functional leaders.
* Communicate residual risks to Quality and Functional leaders.
* Produce Risk Management documentation
Supplier Management:
* Review and assessment of suppliers, audit where applicable. Perform and complete supplier performance ratings and risk ratings. Issue SCAR’s (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 REQUIREMENTS
* A 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 business
* Have 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 systems
* Essential: 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