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Quality Engineer - Medical Devices

Softmed - Melbourne, VIC

Manufacturing & Industrial
Source: uWorkin


Softmed is dedicated to providing the vital personal protective equipment that keeps front-line health workers and all of us safe. No matter how challenging the operating environment, Softmed is committed to meeting our customer’s needs for critical supplies. That’s our promise. Softmed is an Australian-owned company specialising in the manufacture and distribution of healthcare and PPE products. We have a world-class local manufacturing facility for surgical masks, N95 respirators, and other PPE products and the non-woven fabrics that are the raw materials for PPE.

Softmed is currently recruiting for the Quality Engineer role to implement and maintain a robust and efficient quality system as per ISO 13485 to ensure the highest quality output, compliance with Therapeutic Goods Administration (TGA) regulations and maintaining ISO 13485 certification. The Quality Engineer will implement, administer, and support day to day management of the Quality Management System (QMS) and as appropriate, ensuring compliance with global GMP requirements.
The QA Engineer will prepare, check, and assist the Quality, Production and Engineering and Logistics department with ensuring all records of the QMS (e.g., change controls, Design and Development files, Design validations, investigations, continuous improvement, protocols and reports etc.) are completed in a compliant and timely manner.
Report directly to the Head of Quality and Regulatory Affairs in championing a quality culture throughout the business through the development, implementation and continuous improvement of policies, procedures and systems that safeguard medical device products. This includes supporting the business and quality department in the design, implementation, and continuous improvement of a robust and effective Quality Systems.

Primary Responsibilities

• Implement and maintain Device History records generated from core QMS processes and systems.
• Ensure processes needed for the QMS are documented and appropriate for the business.
• Report on the effectiveness of the QMS and any need for improvement
• Ensure awareness of applicable regulatory and QMS requirements throughout the business.
• Deliver or assist with staff training in QMS requirements as applicable.

Competency/Skill Requirements

• 2-3 years’ Experience in a CAD/CAM preferably Solidworks or Autodesk.
• Experience in a design and process validation such as IQ, OQ, PQ.
• Excellent analytical, written, and verbal communication and presentation skills.
• Experience in training staff members in Quality systems.
• Experience in managing multiple projects and deliverables to agreed timelines.
• Experience in managing documentation projects and multiple documentation deliverables.
• The ability to understand high level technical concepts and requirements of end users.
• Proven experience using Microsoft Office applications.


• Previous experience in a quality or manufacturing engineering role, or similar, within a highly regulated sector such as bio- medical/tech, aerospace or pharmaceutical.
• Experience in an ISO accredited environment, preferably 13485:2016.
• BEng/MEng or relevant tertiary qualification.
• Able to capture and process complex data, through the use of Excel or similar, to display and report findings.


• Sound analytical skills and able to communicate complex matters to a range of audiences.
• Experience in a high paced manufacturing environment; clean room experience is a plus.
• Experience with LEAN manufacturing/Six Sigma and defect reduction tools.
• Experience in developing KPI’s or quality metrics to measure performance.
• Experience of working with a team to drive improvements and efficiency gains.
• Experience of developing and delivering training programs.

Key Result Areas

Quality Management System (QMS)
• Management of QMS, maintaining ISO 13485 accreditation and TGA Essential Principles compliance.
• Schedule and oversight of internal audits and conduct Gap Analysis of QMS.
• Manage Document Control, Change Management and SOP authorisation.
• Manage Corrective and Preventive Action (CAPA) and non-conformance systems.
• Manage the customer feedback process.
• Release production materials for use and finished products to the market.
• Manage Training Programs, jointly with Human resources team.


• Support risk management activities including pFMEA.
• Assist with Verification and Validation activities for revised/new process, software or equipment
• Develop and look for efficiency gains in the business, support Continuous Improvement Programs (CIP)
and drive a culture to reduce defects and improve overall quality.
• Analyse data to develop KPI’s and establish quality metrics for the business.


• Support the development of the production team through ongoing quality and compliance training.
• Work with the team to drive Operational Excellence.

Decision Making Levels

• Develops and implements quality procedures, change/document requests and revisions for the efficient running of QMS; adapt systems in line with changing regulatory environment and legislation.
• Determines how to meet senior management directives through the design and delivery of training programs.