Quality Manager

Leading international medical device development and manufacturing company.

  • Senior management position
  • State-of-the-art facility
  • Global focus
  • World-leading team
  • Report directly to CEO

A rare and outstanding opportunity to join a groundbreaking company that is changing the world of microfluidic product development. Located in Scoresby, but with a global presence and outlook, Minifab is revolutionising the creation and manufacturing of diagnostic and life science products.

As Head of Quality, your role will be to develop, strengthen and drive the existing quality culture through the entire business – championing the QMS so that it becomes a mindset of all staff members across every department, level of superiority and geographic location.

Are you ready to think big?

The key responsibilities of this role include:

  • Champion and enhance the quality culture across the entire organisation
  • Help the business achieve excellence based on risk management and best practice quality leadership
  • Provide strategic oversight and direction for QMS and regulatory compliance
  • Maintain and continuously improve an effective QMS with engagement throughout the business
  • Support the QMS across development and manufacturing activities by integrating with leadership teams
  • Attract and develop leading talent to support and develop the quality department within a growing organisation
  • Conduct Management Reviews
  • 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
  • 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
  • Ensure that quality product is released to our clients to agreed schedules
  • 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 a 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

Be part of something special. Take your career to the next level and help drive this exciting company into the next phase of expansion and excellence. Apply by providing your CV and cover letter in word format (no PDFs please).

If your skills and experience match the above criteria, then please apply with your CV and covering letter in Word format to [email protected]

Questions can be referred to Melissa Behrend at [email protected] or +61 3 9764 2241

The future belongs to those who think big.
Head of Quality

Your chance to work at the leading edge of diagnostics and lifescience

We partner with clients to design, develop and manufacture game-changing point-of-care and life-science devices that can place the power of an entire lab in the palm of your hand.

The products we help create are revolutionising healthcare delivery, powering new discoveries, and changing the world. The devices may be small but their impacts are huge.

Join the team at Minifab and become part of this healthcare revolution.