MiniFAB is a world leading medical device development and manufacturing firm, specialising in creating custom made diagnostic and life science products for their strong client base, and manufacturing these cutting-edge products at their state-of-the-art facility located in Scoresby.
A unique and exciting opportunity has arisen for an experienced QA professional to take on the role of Head of Quality (Quality Manager). The Head of Quality will be responsible for continuing to develop, strengthen, and drive MiniFAB's existing quality culture throughout the entire business - Championing their QMS so that it becomes a mindset of all staff members across all departments and all seniority levels.
The Head of Quality will lead a team of talented Quality Specialists, and report directly to the CEO.
The key responsibilities of this role include:
- Champion the Quality culture across the whole organisation to achieve excellence based on risk management and best practice
- Provide strategic oversight and direction for QMS and regulatory compliance
- Support of QMS across development and manufacturing activities by integrating with leadership teams
- Ensure that quality product is released to our clients to agreed schedules
- Maintain and continuously improve an effective QMS with engagement throughout the business
- Provide leadership within the group to attract and develop suitable talent to perform the functions of the department within a growing organisation
- Oversee the Documentation System and ensure best practice with respect to GMP, GDP, ISO 13485, and ISO 9001
- Ensure successful and timely audit outcomes for internal, client, and Notified Body audits
- Develop Quality Metrics, and coordinate quality data collection and analyses to support all business units
- Conduct Management Reviews
- Present MiniFAB's QMS and Quality culture to both internal and external stakeholders
- Provide support and training for staff across all aspects of the quality system
- Manage Change Control, Non-conformances, Deviations, Complaints, CAPA's, Verification, and Validation activities
- Work closely with the PD, manufacturing and production departments of the business to ensure quality products are released from the manufacturing environment
Essential Skills and Requirements:
- Bachelor's degree in relevant science or engineering discipline
- Minimum 10 years QA experience, preferably in a medical device manufacturing and development environment
- Minimum 5 years' experience in a quality management role, in a regulated environment including manufacturing and development (medical devices preferred)
- Excellent leadership, communication (oral and written), and relationship skills
- Experience operating e-QMS software
- A passion for leading based on critical characteristics, measurement system analysis, design of experiments, process capability, lean, six sigma, monitoring, and value streams
- Working knowledge of ISO 13485:2016, European Medical Devices Directive (MDD) 93/42/EEC and its recent update, the US Code of Federal Regulations 21 CFR 820, and ISO 9001:2015 and ISO 9001:2015 requirements, Quality System Regulations and Good Manufacturing Practices is a distinct advantage and a requirement of the role
- Awareness of wider implications of quality across multiple business areas
- Ability to work independently with strong team building skills
- Demonstrable analytical and complex problem-solving skills
- Proficiency with MS operating systems and software
- Statistical analysis competence
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.