QA Manager
2 weeks ago
**Primary job purpose**:
**Management responsibility for**:
- ** Ensuring that Leica Biosystems Melbourne quality system requirements are effectively established, implemented and maintained.**:
- ** Management representative reporting the performance of the quality system and any need for improvements to management with responsibility for review.**:
- ** Ensuring the promotion of awareness of quality, regulatory and customer requirements within the organisation.**:
**Major Responsibilities**:
- **All activities to be carried out within the appropriate ISO13485, 21 CFR parts 803, 806, 820, EU IVD Directive, Brazil ANVISA regulations and Health Canada Regulations.**- **To oversee the maintenance and improvement of the quality system.**
- ** Managing quality system**:
- ** Compliance to international standards**:
- ** Raising quality and regulatory compliance issues promptly to management**:
- ** Effectively manage QA staff**:
- ** Organise monthly Quality Review Board Meetings and six monthly Quality Management Review Board Meetings.**:
- ** Understands strategic direction of the business and deploys agreed actions to align regulatory affairs with key company activities and report activities to management.**:
- ** Ensure all products are released in compliance with Device Master Record.**:
- ** Inculcating a quality culture.**:
- ** Operational decisions based on quality metrics**:
- ** Compliance to procedures and processes**:
- ** Sense of pride in our quality systems**:
- ** Ensure risk management files are maintained.**:
- ** Co-ordinate the compilation of Technical File and regulatory submission documentation where required.**:
- ** Representing QA function internally and externally.**:
- ** Contribution to monthly management reports/meetings**:
- ** Promote awareness of regulatory and customer requirements within organisation**:
- ** Responsible for liaising with regulatory bodies and consultants.**:
- ** To provide advice and reports to senior management regarding quality issues associated with LBS products.**:
- ** To provide a safe working environment, all activities to be carried out within the health and safety policy.**:
**Essential**:
- Highly effective management skills to manage a QA team and drive quality improvement in organisation.
- Fully conversant in the FDA QSR regulatory regime.
- Fully conversant with ISO13485.
- Specific experience in complying to European Medical Device Directive or IVD Directive.
- Conversant with ANVISA and Health Canada regulations.
- At least 5 years experience in a senior QA management position.
- Degree qualified, preferable in Engineering or Science.
- Excellent leadership and coaching skills.
- High ethical standards.
- Excellent problem solving and negotiation skills.
- Ability to develop, train and implement new improved processes and systems.
- Excellent communication skills in a range of situations;
- effective at encouraging and coaching teamwork,
- assertive, able to coach and correct at all organisation levels.
- Highly organised with an eye for detail.
- Self motivated with high energy and passion for quality.
- Process validation experience is required.
- Quality auditing experience is required.
- Excellent computer skills.
- Must be able to handle multiple tasks/ projects and manage priorities accordingly.
- Strong awareness of technical standards basic to a medical device company.
- Must be experienced in dealing with notified bodies and regulatory agencies directly.
- Knowledge of and exposure to manufacturing and engineering processes
**Desirable**:
- Firsthand experience with FDA audits.
- Familiar with other regulations e.g. Japanese, UL, packaging and environmental requirements etc.
- Knowledge of histology.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful **Danaher Business System** tools and the stability of a tested organization.
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
If you’ve ever wondered what’s within you, there’s no better time to find out.
