Quality Compliance Manager

CPL

CORK

Key Competancies. • Sufficient knowledge, interpersonal skills and communication skills to attract respect and exert influence within the team. • Customer focused, with excellent communication skills. • Ability to work under pressure, manage multiple workstreams and meet deadlines. • An ability and desire to support, motivate and develop others. • Problem analysis and problem-solving with excellent attention to detail and accuracy. • Excellent Organisation, Report Writing, Communication, Problem Solving and Presentation Skills. • Sound Decision Making and Negotiation capabilities. • Adaptable and capable of working on own initiative. • Proven knowledge/skills with MS Excel/ MS Word/ MS PowerPoint / Quality Management (CAPA) systems. Requirements. • Minimum of 2 years Quality Assurance or Quality Management experience, at minimum Supervisory level, within the Medical Devices sector. • Applied knowledge of ISO13485:20016, ISO9001:20015, CE Marking/Council Medical Devices Directive 93/42/EEC, Guidelines on Good Distribution Practice of Medicinal Products for Human Use 2013/C 343/01. • Relevant training or experience working within a GDP regulated environment for pharmaceutical storage and distribution. • Hands-on experience of leading regulatory audits. • Knowledge of Regulatory Affairs requirements with ability to review and interpret salient information. • Knowledge of / or applied experience would be advantageous in: Risk Management Systems/Frameworks. • Knowledge of/ or applied experience would be advantageous in: MEDDEV Guidelines on Medical Devices Vigilance Systems and Falsified Medicines Directive. • Excellent presentation skills essential; an ability to present and provide instructor led training as required to colleagues at all levels through the organisation. • Must be available for travel to attend business reviews within Ireland, UK & NI. CplCorkDec2019.

1567 days ago