Quality Management Specialist
7 days ago
Job Title: Quality Management Lead
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Job Description:
">The Quality Management Lead will be responsible for championing quality within the organization, leading and supporting quality management processes and teams. This includes monitoring, maintaining and improving the purpose-built Quality Management System in accordance with ISO 13485 and ISO 9001 standards.
">The successful candidate will ensure overall compliance to standard operating procedures in line with the QMS, develop audit programs and plans, perform internal audits and coordinate external audits.
">This role requires identifying, planning and documenting opportunities for improvement in company processes and systems, working with subject matter experts to drive implementation.
">The Quality Management Lead will manage and process CAPA related activities, identify and advise on relevant standards and regulation for product developments, maintaining up-to-date libraries of applicable standards and regulation across global markets.
">They will facilitate company and product development risk management in accordance with best practices, including ISO 14971, IEC 60812 and ISO 31000.
">The Quality Management Lead will facilitate appropriate identification and records of product user needs, requirements verification and validation activities and traceability throughout development.
">They will manage quality for the development of medical devices according to regulation such as CE MDR, FDA and TGA and standards including ISO 13485, IEC 60601 and IEC 62304.
">Additionally, the Quality Management Lead will manage the calibration of test and measurement equipment, select and evaluate suppliers, monitor quality agreements, and manage actions arising from goods inspection.
">Required Skills and Qualifications:
">A relevant qualification from a reputable education organization is required.
">At least 5 years' experience in quality management or a similar role is necessary.
">In-depth knowledge of ISO 13485 and ISO 9001, as well as regulatory requirements pertaining to product development, is essential.
">Understanding of a variety of production/manufacturing processes is also required.
">Experience in communicating with and evaluating local and offshore suppliers is necessary.
">Excellent verbal and written English communication skills are required.
">Ability to work independently and as part of a team is essential.
">Benefits:
">We provide comprehensive design services to leading companies.
">Our team spans industrial and mechanical design, electronics, embedded systems, iOS, Android, Linux app, web servers, and more.
">Workplace flexibility is valued, and remote work options are available to support work-life balance.
">Keyword: QualityManagement
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