- Innovative& Award Winning Products
- Employer of Choice, Rapidly Growing Markets
- Dynamic& Rewarding Work Environment
Our client is a leading medical device multinational
with operations globally. Sustained growth over the past decade has led to
increased market share and exposure to new markets.
with operations globally. Sustained growth over the past decade has led to
increased market share and exposure to new markets.
To support this growth a new opportunity has arisen
for an experienced Quality Director to join our client’s Sydney based operations
in ensuring the highest commitment to quality systems, regulatory compliance
and product quality.
for an experienced Quality Director to join our client’s Sydney based operations
in ensuring the highest commitment to quality systems, regulatory compliance
and product quality.
This is an excellent opportunity for highly capable
and ambitious quality professionals looking to further their career in a
dynamic and rewarding work environment
and ambitious quality professionals looking to further their career in a
dynamic and rewarding work environment
Responsibilities:
- Design, develop and maintain quality assurance
management plans across all areas of the business - Ensure compliance with national and
international standards and legalisations - Develop and manage quality assurance metrics
for performance improvement of all teams - Evaluate and enhance quality assurance
standards, technologies and approaches according to regional and global
requirements - Implement ongoing quality improvements and
processes across all areas - Identify deviances from standards and suggest
modifications to ensure compliance - Develop and monitor quality budgets and
spending - Interface with regulatory agencies and manage
regulatory audits as required ( FDA, ISO,PMDA, International) - Manage quality engineers, lab lead, lab tech
and other technical quality functions to support manufacturing and
development programs - Manage quality assurance projects to meet
stakeholder requirements
Requirements:
- Bachelor of Science or equivalent with a
minimum of 10 years practical experience in Quality or Engineering within
the medical device, consumer electronics or defence industries preferably - Knowledge and experience with FDA, ISO 9001
and 13485 - Excellent verbal and written communication
skills - Knowledge in risk management , design control,
process validation, inspection and auditing - ASQ Quality Engineer, Quality Manager
and /or Six Sigma Black Belt certification desirable - Strong analytical and problem solving skills.
Remuneration:
Salary: $ Excellent plus benefits &bonuses
For more information, or to apply, call Diarmuid on
+61 2 8096 0060 / email your application to dsexton@adroitpeople.com.au
+61 2 8096 0060 / email your application to dsexton@adroitpeople.com.au
Confidentiality Assured.