About Saluda Medical Founded in 2013, Saluda Medical is dedicated to transforming patients' lives with disruptive neuromodulation solutions. As leaders in the field, we have achieved exceptional pain management results through more than a decade of advanced research, development, and clinical experience. We are a global healthcare company redefining Spinal Cord Stimulation (SCS) therapy at the intersection of automated algorithms, real-time diagnostics, and groundbreaking clinical evidence. Our advanced neuromodulation systems for the next generation of implantable stimulation devices are distinguished by Dose-Control Technology via measurement of physiological response. What We’re Looking For Working with a team of engineers and Quality Control Inspectors as our Senior Quality Engineer/QC Supervisor you will be responsible for ensuring the appropriate quality controls, improvements, and production related quality system are effectively implemented in the manufacturing facilities. You will also be responsible for ensuring the products are manufactured in accordance with applicable regulatory requirements, controlled QMS procedures and work instructions, customer expectations, and industry standards. Your role will include: Mentor Quality Engineering team on compliance and improvements related issues. Supervise and support Quality Control Inspectors, facilitating prioritisation of QC tasks. Monitor and maintain the Saluda Quality Management System (QMS) to ensure compliance to ISO 13485 and applicable regulatory requirements. Ensure all requirements of QMS related to Receiving, Goods Inwards, Production and Distribution are planned for and implemented withing the QMS. Support DHR, DMR and DHF compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained. Liaise across business functions to ensure the product design/development teams and manufacturing operations translate design requirements into manufacturing requirements during design transfer to increase manufacturability, reduce scrap and improve operational efficiencies. As needed, collaborate with product development team to ensure Design for Manufacturing has been considered in New Product Introduction. Ensure QMS is implemented in full, with records maintained to support compliance to both local and international regulatory requirements, whilst maintaining an audit ready status. Supporting non-conformance process, providing standards and direction, leading corrective and preventative activities. Ensure prompt investigation and action and escalate quality issues based on appropriate analysis. Initiate NCR and CAPA investigation and take actions as required including driving required changes to completion. Assist management in implementing the company policy and company objectives. Ensure records are maintained to allow measurement against them. Participate in internal audits to ensure company's quality system is effective. Assist development and maintenance of Manufacturing Quality Plans for quality control to ensure manufacturing process and product conformance. Continually assess the end-to-end process to ensure efficient, effective, predictable, and timely quality control activities and provide metrics for Data Analysis and Management Review. Analyse data to identify trends in product quality or defects with a goal of mitigating and preventing recurrence and future defects. Identifies root causes of problems in the production process; recommends and/or implements corrective measures. About you: A bachelor’s degree or higher in Materials Science, Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or related Engineering discipline. 6-10 years’ experience in Medical Device Manufacturing environment. Critical thinker with High-level analytical and problem-solving skills Communicate effectively, drive execution, foster innovation, focus on the customer, collaborate with others, solve problems creatively and demonstrate high integrity. Proven self-starter/able to take initiative, detailed oriented. Advanced written and verbal communication skills and ability to produce reports & presentations to a professional standard. Effective time-management, interpersonal and analytical skills. A proven ability to successfully lead and mentor people. Ability to implement quality and regulatory procedures to meet organisational objectives. Ability to maintain professional internal and external relationships. Knowledge of medical device regulatory requirements. An understanding of the requirements of ISO 13485:2016 and/or 21CFR 820 Knowledge of Risk management requirements (ISO14971). It’s not essential, but nice if you have: Product lifecycle management system development Project Management People management experience At Saluda, we challenge boundaries. We innovate and think beyond the conventional. We disrupt. Are you Ready to Join? If you would like to be part of our team developing the world's next generation of implantable device technology, contribute to making an impact on patient care, then this is the opportunity for you! Please APPLY NOW! Applications will only be considered from candidates with the appropriate approval to work in Australia, no visa or sponsorship is available for this role. All eligible candidates are invited to apply. We respectfully ask for no agency approaches.
