Operations Manager

ICDS Recruitment

Worldwide

Operations Manager - Nashua, New Hampshire, USA. Job Overview: Our client, a European notified body for medical devices, seeks to recruit a US Operations Manager for it's facility inNashua, New Hampshire, USA. Key Tasks and Responsibilities: Manage a team of medical device auditors and in-vitro diagnostic device auditors. Recruit, train, manage induction and authorise auditors. Plan and manage audits in conjunction with client service representatives as well as resources from other geographies. Assess competency and develop and manage training programmes for auditors. Perform and manage witness audits of the auditors. Liaise with auditors in relation to site, standard, and regulatory issues. Manage technical review of audit packages. Provide auditors with real time support whilst they are on site. Engage with auditors post-audit and ensure responses to non-conformances are addressed in a timely manner. Manage the certification review team and attend technical review meetings for the registration, re-certification and technical changes or amendments to existing certifications for all accredited programmes. Responsible for maintenance and development of all associated Quality System Documentation and effective execution of all activities assigned to the Operations Manager. Organise internal audits and review the non-conformances associated with this. Function as the deputy Management Representative for all management systemactivities. Responsible for external accreditation audits and the investigation,corrective action and effective close out of any non-conformances which arise. Keepthe CAPA system up to date. Responsible for communications with associatedaccreditation bodies including external audit preparation, corrective actions, invoicingand any other associated requirements. Review and implement accreditation updates/bulletins. Liaise with clients in relation to quotations, contracts, audit planning and site issues ifthey arise. Attend periodic meetings with key clients. Maintain and manage client feedback and complaint system in accordance withprocedures. Plan and oversee unannounced and for cause audits in conjunction with theunannounced audit co-ordinator as well as Head of Medical Devices and otherOperations Managers. Attend meetings and conferences and promote the organisation at international level. Co-operateand work with the Business Development and Marketing functions in order tomaximise the marketing potential of the Medical Device operations and themaintenance of Client Relations. Prepare net revenue, performance reports and business plans. Perform an active rolein management review activities for medical devices. Participate as a member of the leadership management team. Qualifications and Experience sought: Essential- • A qualified lead auditor with extensive experience in ISO 13485, ISO 9001, ISO17021, MDSAP, MDD, IVDD. Successful completion of a university degree or technical college degree orequivalent qualification in relevant studies such as: medicine, pharmacy,engineering or other relevant sciences. Extensive knowledge of the aforementioned standards, medical device directive,active implantable device directive, in vitro diagnostic device directive, medicaldevice regulation, in vitro diagnostic device regulation. At least four years' experience in the field of healthcare products or relatedactivities such as manufacturing, quality assurance, regulatory affairs, orregulatory auditing. Extensive knowledge of medical device quality management system auditing, evidence of knowledge and experience of quality management system standards. • Extensive knowledge of the MDSAP scheme. Knowledge and experience of risk management and related device standards and guidance documents. Knowledge and experience of the conformity assessment procedures in the aforementioned directives and regulations. Ability to draw up records and reports. Desirable: Exceptional writing and presentation skills. Excellent planning, organisational and administrative skills. This job originally appeared on RecruitIreland.com.

1979 days ago