Quality and Operations Technician

2 weeks ago

Newstead, Australia Convergence Medical Full time

**About the job**

**Who Are We?**

**Position Overview**

Our professional and friendly team are seeking a dynamic self-starter to join us as our Quality and Operations Technician. You will be solutions focused and ensure the quality of our company and our products through meticulous administration. This role is ideal for someone with a passion for the highest quality standards, a desire to contribute to the development of cutting-edge surgical technology within a highly regulated and technical environment. The role will suit someone with a very keen eye for detail, excited to upgrade their skillset by learning from groundbreaking leaders in the industry.

**Key Responsibilities**
- Assist in the establishment and maintenance of the Document Management System and company registers
- Ensure GMP & MDSAP compliance for all procedures and policies.
- Follow quality control procedures to ensure product consistency
- Coordinate the QMS and take responsibility for QMS activities
- Manage change control and deviation management processes.
- Coordinate with development and production teams to monitor and document product quality at various stages of production.
- Provide technical and quality advice to internal departments and stakeholders
- Maintain existing licenses and acquire required licenses/certificate as needed.
- Work closely with the compliance team to ensure that all quality assurance practices align with legal and regulatory requirements.
- Assist in preparing for and participating in internal and external inspections and audits.
- Experience in setting up and maintaining systems including ERP’s, CRM, Project Management Software and similar. Preferred but not essential.

**Key Criteria**
- Appropriate tertiary qualifications. Engineering qualification preferred, however not essential.
- Strong expertise in systems management
- QA and QC skills and experience
- Excellent working knowledge of TGA, GMP, ISO and MDSAP highly regarded
- Excellent attention to detail, time management, organizational and administrative skills.
- Strong communication skills, both written and verbal, with the ability to convey technical information clearly.
- Ability to work independently and collaboratively
- Excellent communication and relationship building skills
- Ideally 2+ years of experience working in a similar role within the medical device industry

If you would like to apply, please do so through the Application button on the ad and we will be in contact.

Pay: $65,000.00 - $75,000.00 per year

**Benefits**:

- Work from home

Schedule:

- Monday to Friday

Application Question(s):

- What's your expected annual base salary?

**Education**:

- Bachelor Degree (required)

**Experience**:

- Quality: 1 year (required)
- ISO 13485, MDSAP and cGMP.: 1 year (preferred)

Work Authorisation:

- Australia (required)

Work Location: In person

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