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
The Quality Manager is responsible for developing, strengthening and driving the quality culture through the entire business. This includes championing the Quality Management System (QMS) so that it becomes a mindset of all staff members across the organisation. This role works closely with the PD and manufacturing departments of the business to ensure quality products are released from the manufacturing environment. This role sits within a matrix structure and reports into the CEO. The Quality Manager currently has a team of 1 direct report and 3 shared reports (matrix structure), comprising quality engineers and quality specialists.
The key responsibilities of this role include:
- Partner with functional groups across the business and use quality team resources to support the functions to achieve their goals
- Drive 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
- Provide leadership to the Manufacturing Quality Engineering function
- Support Change Control, Non-conformances, Deviations, Complaints, CAPA’s, Verification, and Validation activities
- Responsible for Quality release of product in line with MFG supply plan
- Present Minifab’s QMS and Quality culture to both internal and external stakeholders
- Develop an ISO 13485 QMS that is an enabler of efficient and effective value creation by functional groups
- 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
- Steer the functional groups to be consistent with our QMS requirements
- Provide support and training for staff across all aspects of the QMS
- Oversee the QMS Documentation and support best practice with respect to GMP, GDP, ISO 13485, and ISO 9001
- Audit, measure, and report on performance
- Develop Quality Metrics, and coordinate quality data collection and analyses to support all business units
- Ensure successful and timely audit outcomes for internal, client, and Notified Body audits
- Conduct annual Management Review
Essential Skills and Requirements:
- Bachelor’s degree in a relevant science or engineering or related discipline
- Minimum 7-10 years QA experience within a manufacturing environment (ideally within a medical device manufacturing environment but not essential).
- Demonstrable analytical and complex problem-solving skills
- A self-starter with the ability to work in cross-functional teams to successfully deliver projects to the highest standards
- Either demonstrated experience as a successful team leader, coach and mentor or the ability to step up into a leadership capacity.
- A strong customer focus with the ability to adapt to changing priorities in a calm manner
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 2241The future belongs to those who think big.
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.