Quality Officer - 6 month max term contract
Irvine, CA
Quality and Regulatory – Quality /
Max-Term Contract /
On-site
Planet Innovation (PI) is a globally recognised Healthtech Innovation and Manufacturing company. PI offers the full spectrum of product design, engineering and manufacturing services for its customers in the diagnostics, life sciences and healthcare industries. Our clients include many of the world's top medical device companies, as well as some of the world's most exciting medtech start-ups.
With HQ in Australia and the majority of its customers in the US, PI established a world-class manufacturing facility in Irvine, California in 2021 and this division is growing rapidly on the back of high demand for our production services by both existing and new clients.
PI has an authentic, transparent, supportive culture and we offer a broad array of comprehensive benefit programs for our employees, including medical, dental, vision, 401k with employer match, and paid vacation, holidays, and sick leave.
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
At PI, we believe that work is ‘what we do’ not ‘where we go’. That belief has seen us introduce new Ways of Working that empower our people to choose where, when and how they work to produce their best outcomes. It can include a combination of working from home, the newly reimagined and refurbished office, a café or a co-working space. And the rigid 9-5 workday, 5 days a week has gone. You can learn more here: https://planetinnovation.com/perspectives/how-pi-is-giving-staff-the-freedom-to-match-their-work-style-to-their-lifestyle/
To Apply
A positive, high-achieving work culture, and plenty of opportunities to learn and grow await you at Planet Innovation, so apply now.
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.
Please note only applications with the right to live and work in the US will be considered for these positions.
No recruitment agencies, please.
