We have an opportunity for a dynamic Quality Manager to join an agile and creative medtech start-up, ZiP Diagnostics.
You will be part of a team creating innovative point-of-care tests against human and animal infectious diseases. You will be improving health and well-being globally. You will help to improve access to healthcare, especially in community-based settings and low-middle income countries. You will be part of a diverse team of skilled R&D scientists, production scientists, and engineers. You will be based at our new facilities in the inner-Melbourne suburb of Collingwood.
Effective Date: Immediate appointment Your responsibilities will include: Manage and maintain oversight of the company Quality Systems, including Documentation Control, Non-Conformance, CAPA, Change Control, Training, Complaints, Vendor Assurance, Internal Audits, Batch Review and Release, Quality Control (incoming inspection, final release), Validation and Calibration.Act as Management Representative: ensures the processes needed for QMS are documented; manage and report to top management on the effectiveness of QMS and any need for improvement; promotion of awareness of regulatory and QMS requirements throughout the organisation.Act as QMS liaison with customer representatives.Act as QMS interface with regulatory and / or compliance bodies (e.g. TGA, FDA and EU).Direct quality personnel to support new product development by defining projects focused on new products/process development based on coordination with management, project leaders, & scientists.Implement improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.Ensure sustaining support of the Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.Manage product traceability and labelling.Manage and maintain product device history records.Regulatory planning.Other duties as requested. Essential Selection Criteria: Minimum of 5 years' experience in the management of ISO 13485 and 21CFR 820 quality management systems.Experience with the requirements of regulatory approval agencies including TGA, CE and FDA. Experience with writing and submission of medical device technical files would be advantageous.Experienced internal and supplier auditor. Audit qualification would be advantageous.Experience with clinical trials would be advantageous.Self-driven individual with excellent work ethic and a can-do attitude.Active learner with the ability to thrive in a fast-paced, results oriented, start-up environment.True team player with strong interpersonal skills and commitment to the team's success. Creative problem solver with exceptional verbal and written communication skills.Excellent time management skills with keen attention to detail and ability to multi-task.Excellent procedure and report writing skills.Experienced manager of staff. Desirable Selection Criteria: Experience working in the in vitro diagnostics industryExperience in cleanroom manufacturingExperience working with ISO or NATA Quality Management SystemsRemuneration: According to experience. To apply:
Written applications addressing the selection criteria and a detailed resume should submitted by 29th November 2024