Senior Quality Systems Specialist

Vor 6 Tagen

Council of the City of Sydney, Österreich Saluda Medical Vollzeit

Senior Quality Systems Specialist 12 Month Fixed Term Contract – Part Time (4 days/week) Location: Macquarie Park, Australia Position Profile: Saluda Medical was founded in 2013 to transform patients’ lives with disruptive neuromodulation solutions. We are leaders in the field with proven exceptional pain management results and, with more than 10 years of advanced research development and clinical experience, we design and develop advanced neuromodulation systems for the next generation of implantable stimulation devices. Reporting to the Director, Operations Quality and Quality Systems, the Senior Quality Systems Specialist is responsible for maintaining the company’s quality management system. Note: This is a 12‑month Part‑Time Fixed Term role. Hours are flexible and can be adjusted to suit business and individual requirements. Accountabilities and Associated Responsibilities Develop and maintain the quality management system across all aspects of the company to assure compliance to ISO 13485:2016 and all applicable international standards and regulations. Manage the internal audit program and conduct internal audits to assure Saluda products quality systems. Act as internal coordinator for all audits and inspections of regulatory and quality nature, including unannounced audits. Manage the change control process and process changes made through the change control procedures. Manage the CAPA process. Support development and validation of any quality management related software. Ensure an effective training program is implemented and maintained. Administer the quality planning process. Administer the management review process. Other duties as directed by the Manager. Essential Requirements Tertiary qualifications in engineering or science. At least 3 years of professional experience in a quality function in a medical device or pharmaceutical company. Proven ability to execute and implement/maintain quality systems. Strong relationship builder and communicator with experience in diverse work teams. Demonstrates integrity and reliability, strives for excellence in work. Desirable Requirements Experience with implantable/active implantable medical devices. Document management experience. Internal audit training and experience. #J-18808-Ljbffr

  • Quality Systems Specialist

    vor 3 Wochen

    Council of the City of Sydney, Österreich Saluda Medical Vollzeit

    Quality Systems Specialist - 12 Month Fixed Term Contract Location: Macquarie Park, Australia Manager Director, Operations Quality and Quality Systems Position Profile Saluda Medical was founded in 2013 for the purpose of transforming patients’ lives with disruptive neuromodulation solutions. We are leaders in the field with proven exceptional pain...

  • Quality Systems Specialist

    vor 3 Wochen

    Council of the City of Sydney, Österreich Saluda Medical Vollzeit

    A leading medical device company is seeking a Quality Systems Specialist for a 12-month fixed term contract in Macquarie Park, Australia. The role focuses on developing and maintaining the quality management system, ensuring compliance with ISO 13485:2016 and conducting internal audits. Candidates must have tertiary qualifications in engineering or science...

  • Quality Systems Specialist

    vor 2 Wochen

    Council of the City of Sydney, Österreich Medtronic Vollzeit

    A Day in the Life Quality is everyone's responsibility! Medtronic is a world leader in providing health‑care products that restore health and extend life. The Medtronic Diabetes Quality team contributes directly to this mission. We are looking for a Quality Systems Specialist to join the Australian Quality team to ensure a mature and compliant quality...

  • Senior Quality Assurance Specialist

    Vor 2 Tagen

    Council of the City of Sydney, Österreich GN Group Vollzeit

    At GN Hearing were driven by a simple but powerful purpose : to make life sound better. As one of the worlds leading innovators in hearing solutions we combine cutting-edge technology quality and care to transform lives every day. We’re now looking for a Senior Quality Assurance Specialist to join our high‑performing Operations team in Sydney. This role...

  • Quality Systems Specialist

    Vor 6 Tagen

    Council of the City of Sydney, Österreich Medtronic Vollzeit

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. Medtronic is a world leader in providing health care products that restore health and extend life. The Medtronic...

  • Senior Quality Systems Lead, Medical Devices

    Vor 6 Tagen

    Council of the City of Sydney, Österreich Saluda Medical Vollzeit

    A leading medical device company is seeking a Senior Quality Systems Specialist for a 12-month part-time fixed term role in Macquarie Park, Australia. The successful candidate will develop and maintain the quality management system, manage internal audits, and ensure compliance to ISO 13485:2016. Ideal candidates have tertiary qualifications in engineering...

  • Quality Systems Specialist — ISO 13485

    Vor 6 Tagen

    Council of the City of Sydney, Österreich Medtronic Vollzeit

    A leading medical technology company in Australia seeks a Quality Systems Specialist to ensure compliance and enhance quality management systems. You'll lead initiatives to maintain adherence to quality standards like ISO 13485 while collaborating with cross-functional teams. This position offers competitive salary and flexible benefits, contributing to the...

  • Systems & Quality Specialist

    vor 14 Stunden

    Newcastle City Council, Österreich Daracon Group Vollzeit

    Requirements At Daracon Group we value our people as one of our key assets and hold the safety of our workers, contractors and clients as the highest priority. Our commitment to safety, quality and the environment form part of our core values and are a fundamental part of everything that we do. A key part of our ability to deliver on our commitments in...

  • Senior Quality Specialist

    vor 2 Wochen

    Council of the City of Sydney, Österreich Boston Scientific Gruppe Vollzeit

    Additional Locations : Australia-Melbourne Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With...

  • Systems & Quality Specialist

    vor 4 Wochen

    Newcastle City Council, Österreich Daracon Vollzeit

    At Daracon Group we value our people as one of our key assets and hold the safety of our workers, contractors and clients as the highest priority. Our commitment to safety, quality and the environment form part of our core values and are a fundamental part of everything that we do. A key part of our ability to deliver on our commitments in regards Health,...