Minifab is a world leading medical device development and manufacturing firm, specialising in creating custom diagnostic and life science products for their strong client base. Manufacturing of their these cutting-edge products is carried out at their state-of-the-art facility located in Scoresby.
An exciting opportunity has arisen for an experienced Quality Engineer to join their team on a full-time permanent basis. The Quality Engineer will ensure that new products are developed with adherence to design requirements, corporate quality goals, and industry best practice. There will also be a focus on the development and implementation of quality engineering systems and tools, so that support is provided to the engineers, and product designs are created with efficiency and ultimately within the project schedules.
The key responsibilities of this role include: (But are not limited to)
- Interpret product requirements and design and develop concepts, components, assemblies, and products in compliance with applicable quality system procedures, industry and business standards, and regulations.
- Participate in cross-functional teams in the development of new products or changes related to current products in meeting design requirements.
- Develop, diagnose, and implement quality engineering systems, including tracking, analysing, reporting and problem-solving using appropriate quantitative statistical methods and tools (Six Sigma, Root Cause Analysis, FMEA, and 8D) to facilitate data analysis and product improvements actions.
- Review designs, changes, processes, and specifications, and ensure compatibility with all requirements and reliability standards. Assist with first off sample approvals where applicable.
- Closely monitor all new product launches ensuring all quality disciplines/procedures are in place, while meeting product development quality objectives and promoting a quality mindset.
- Develop and implement product quality plans, documents and systems by creating quality specifications, quality plans, risk analyses, Design and Process FMEAs in conjunction with cross functional team members.
- Lead Issue Management and report on Key Performance Indicators (KPIs) in order to prioritise and drive timely issue resolution, capture and manage lessons learned, and prevent upstream project reoccurrence of issues relating to product, process, or system.
- Lead training of quality awareness within a product development environment, by creating Quality Engineering Tools & Training Materials based on knowledge/expertise.
- Support development of test and inspection methods, and lead method validation activities.
- Identify opportunities and develop recommendations to improve product/design efficiency.
- Interact with clients on an as-needed basis to support project and sales activities.
- Collaborate with engineers, managers, and wider development, manufacturing, and purchasing teams
- Manage internal and external stakeholders required to support product design tasks
- Attention to detail and self-motivation to deliver work to the highest standards
- Multitasking, planning work, scheduling tasks, coordinating activities, and managing time efficiently
- Presentation of designs and/or issues both internally to stakeholders and externally to clients.
Essential Skills and Requirements:
- A tertiary qualification in mechanical engineering, or relevant engineering discipline
- Significant Quality Engineering experience (10+ years) working as a Product Development Quality Engineer, or within a new product development environment. Prior medical device experience preferred
- Extensive experience in quality management systems including ISO13485, with detailed knowledge of FDA and GMP, and demonstrated use of Quality Engineering tools/methodologies
- Intimate understanding of Design Control, Validation and Verification processes
- Project management and leadership skills, including demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
- Design for Six Sigma and Critical to Quality training and experience preferred
- Extensive and demonstrable experience with Design for Manufacture principles
- Experience working in fast paced, cross functional, innovative, high quality, regulated, engineering environment such as medical device, food, automotive or similar industry is essential
- Proficient computer skills, including statistical/data analysis and Microsoft Office Suite
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organisation
- Excellent attention to detail and self-motivation to deliver work to the highest standards
- Ability to multitask, plan, prioritise, coordinate, and manage time efficiently
- Ability to leverage and/or engage others to accomplish projects
- Must be practically minded and hands-on.
If the above sounds like you, then hit the apply button and provide your CV and a cover letter.
Please ensure that your CV and cover letter are in Word Format (no PDFs).
Questions can be referred to Leah Creswick at Fuse Recruitment on 0478 193 170.
This is an outstanding opportunity for someone to join a rapidly expanding business and be part of ground breaking microfluidic product development that is changing the world.
Dare to think big.