AddressAnteris is a structural heart company delivering clinically superior solutions that help healthcare professionals create life-changing outcomes for patients. We are currently developing the first-in-class biomimetic TAVR valve as a growing and inclusive Medtech team with global office locations in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia. Help us build a team that will shape the future of TAVR.
The Sr Production Technician will actively participate in the manufacture of medical devices in accordance with company procedures and policies as well as agreed plans and timeframes as well as participate in the planning and execution of training of new production staff.
Key Responsibilities:
Production:
- Compliance with SOPs.
- Ensure all staff remain motivated, on task and always practicing GMP and safe manual handling techniques.
- Actively participate in the manufacture of medical devices, as required and ensure all production occurs in accordance with GMP.
- Supervise general laboratory activities pertaining to production of medical devices.
- Evaluate the performance and efficiency of production staff and procedures.
- Evaluate and make recommendations for changes to systems and processes that will enhance product quality.
- Coordinate subordinate staff to optimise the use of human and materials resources to achieve agreed manufacturing targets.
- Develop, revise and review manufacturing documentation as required.
- Initiate and participate in CAPA and change control processes as required.
- Design and Development: participate in new product and process improvement projects as required.
- Participate in the development and management of new or modified process implementation projects.
- Participate in internal and external audits as required.
- Socially inclusive to the unique needs of a global team
- Carry out general laboratory activities pertaining to production of medical devices.
- Cleaning and maintenance of equipment.
Reporting:
- Documentation and reporting of Production procedures and results.
- Stocktaking, requesting, and passing in of materials, equipment and consumables into controlled areas.
- Ability to report findings for any development or project work they participate in.
Training
- Complete GMP training at least once annually; perform trainer duties and other training for assigned duties.
- Complete all required training for assigned duties.
- Ensure all training documentation is maintained and updated.
- Assist in the construction and execution of training activities and documentation.
Skills, Knowledge, Experience & Qualifications:
- Tertiary Qualifications in a relevant scientific field and 3+ years' experience in GMP manufacturing
- Understanding of Quality Systems in medical manufacturing, including an understanding of ISO 13485 and 21 CFR 820
- Attention to detail.
- Understanding of business drivers and need for regulatory compliance.
- Experience in training a small team in a GMP environment.
- Proficiency in the use of Microsoft computer software
- Sound communication and interpersonal skills
