This role, reporting to the Quality Manager, will provide Quality Assurance oversight of Commercial Manufacturing, Materials Management, and Quality Control areas. A particular focus of this role will be to provide support in ensuring the administration and maintenance requirements of Ellume’s QMS are achieved in an efficient and effective manner, and to promote and support engagement and innovation within the wider business.

Duties and Responsibilities

• Provide “on-the-floor” quality oversight to all manufacturing areas to ensure product quality and compliance to SOPs and to cGMPs during all operations
• Perform and/or assist with investigations of quality related incidents that occur on the production floor
• Participate in the continuous improvement of production-related documentation SOPs, forms, etc.
• Ensure batch related documentation is completed accurately and in real time
• Recognize deficiencies and initiate proper follow-up
• Actively perform real-time audit of manufacturing and testing operations
• Provide quality assistance and guidance to employees to clarify quality processes and procedures.
• Engage and collaborate with Operations department to drive quality system and cGMP requirements.
• Review manufacturing Batch Production Records (BPRs) and associated supporting documentation including logbooks, Quality Control (QC) testing reports, and environmental monitoring reports, in support of product release.
• Review and approve compliance documents including SOPs, deviations, change controls, quality records and other documentation required for compliant GMP operations.

Work Experience and Skills

Essential Qualifications:

• Knowledge of cGMP/QSR, ISO 13485 and FDA device/drug regulations.
• Experience in a manufacturing environment highly desired
• Experience with manufacturing investigations, deviations, and CAPA.
• Ability to communicate and work independently with scientific/technical personnel.
• Proficient in MS Word, Excel, Power Point and ERP system.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities.
• Knowledge of how to analyze processes and identify issues.

Desirable Qualifications:

• Experience with Root Cause Analysis tools (e.g. 5 why’s, Ishikawa) and using risk-based thinking or risk-based tools.
• Working knowledge of regulatory requirements for software in medical devices. (ISO62304)

Education and Certification

Essential Qualifications:

• BSc in Engineering or Science Degree or equivalent

Desirable Qualifications:

• Internal or supplier audit qualifications

Quality and Safety

All Employees and Contractors are responsible and accountable for: 

• Compliance with workplace policies for Quality and Safety.
• Active participation in activities associated with the management of workplace health and safety. 
• Active participation in activities associated with the management of quality.

Our Company

Ellume U.S.A. is a proud subsidiary of Ellume Ltd. (based in Brisbane, Australia). We are a Health Technology company that develops and manufactures rapid and accurate digital diagnostics for U.S. medical practitioners and consumers. We achieve this by applying the working practices of our parent organization through the integration of next-generation diagnostics, reader technology and software. Our products are distinguished by their simplicity of use, rapid time to result and connectivity.

• Our Vision - A world where people return to health as soon as possible.
• Our Mission - Through the creation of simple, accurate diagnostic tools and through the linking of the results of those tools to the best treatment, we help people to get better sooner and enjoy their lives.
• Our Purpose - To create rapid, accurate diagnostic tools that link people to optimal therapy.

The Ellume Way

“Making things great” is one of our most important values at Ellume. We work hard every day to create products that will enhance the lives of people in our community, our country, and all over the world. Doing things great is not an option at Ellume. Working here means making a commitment to uphold the “Ellume Way”. 

• Make it great– we care about great products and general execution. The best we can possibly create.
• We are candid– with ourselves and with each other. Sometimes these conversations are hard, and we deal with those conversations thoughtfully and respectfully.
• We are a team– we believe in, support, listen to and respect each other. Together we will achieve great things!
• We can think– we value quiet contemplation and flying ahead of the plane. Thought experiments are the best experiments of all.
• We have a bias for action– thoughts are not our aim. Our aim is great products and great execution which improve millions of lives.
• We are bold – we are open to new approaches, strategies, and processes. Innovation is in our DNA and together we believe we can do the impossible.
• We are ambitious for the company– through success of the company, we all succeed; our customers, our partners, our shareholders, our communities, and ourselves.
• We celebrate– individual and team successes at every opportunity.
• We are driven– to make the future better by inventing it to be so.