Quality Officer

2 weeks ago

Box Hill, Australia Planet Innovation Full time

Planet Innovation (PI) is an award winning healthtech contract design and manufacturing company and we work on some of the most advanced technology in the world. We have our own portfolio of businesses, and also partner with world-leading organizations to help them create game-changing innovations to grow their business. Our clients include some of the world's top medical device and healthcare companies, as well as some of the world's most exciting start-ups.

Creating great products and winning awards is all down to our team. Planet Innovation has over 400 of the brightest and most passionate people on Earth, and we are looking for more.

The Quality Officer works in the Quality Assurance/Regulatory Assurance team to maintain and improve the company’s Quality Management System (QMS). Tasks include activities in design, development, manufacturing, and overall QMS systems; such as reviewing and preparing documents, assisting with QMS maintenance, audit assistance, training administration, product releasing, implementing improvements and team support.

**The Accountabilities**:

- Prepare and manage release of Quality System documents; including procedures, working instructions and templates.
- Support QMS and regulatory activities for general QMS maintenance and improvements.
- Support change control processes.
- Support training activities; including issuing training and maintaining training records.
- Data entry into QA registers.
- Participate in QA team tasks as required, such as system improvement activities.
- Manage PI Standards, including maintaining the register, hardcopies, and purchase standards as requested.

**The Typical Experiences**:

- Formal qualifications in Science or Engineering related field or a minimum of 5+ years Quality Assurance experience.
- Understanding of Quality Systems compliance.
- Experience in Design and Development Quality Assurance.
- Experience in Manufacturing Quality Assurance.
- Familiar with medical device quality standards ISO 13485 and FDA CFR part 820.
- Proficient in document writing for the purposes of preparing procedures, work instructions, templates etc.
- Diligent with high attention to detail.
- Collaborative team player.
- Ability to work independently.

**Flexible Ways of Working**

We are proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees, and all suitably qualified applicants will receive consideration for employment without regard for race, gender, sexual orientation, religion, disability, or age.

No recruitment agencies, please.

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