We’re looking for a focused, energetic candidate with a “can-do” attitude to join our Quality team. You will play an important role on-site by assisting the team with day to day activities. This position is a well-rounded training opportunity focused on learning and developing experience within the positive SHOEBOX work environment. This is also an opportunity to make a real impact on the world by furthering our mission to expand hearing healthcare around the Globe with our innovative mobile and web-based medical solutions, and to work with an amazing (seriously, amazing) group of brilliant and passionate people.
Why we need you:
As a developing Quality Assurance professional, the opportunity to immerse yourself in the regulated environment of a Medical Device software company fascinates you. The chance to interact across various departments within the company is equally exciting. To top it all off…you like hands-on, process-driven work. It’s really satisfying to check off the boxes on your lists at the end of each day.
Your primary responsibilities:
- Serve as primary contact for the return merchandise authorization (RMA) process (the process of returning a product to receive a refund, replacement, or repair)
- Inspect returned materials according to acceptance criteria and receive back to inventory.
- Inspect outgoing orders according to acceptance criteria prior to shipment.
- Ensure effective implementation of QMS processes by monitoring QA systems and advising QA leadership on system performance
- provide status reports of quality activities
- Create and maintain QA control documentation, analyze data, and generate reports as required by company SOPs and regulatory requirements
- Assist with document control, records control, non-conforming material, corrective and preventive action, investigating complaints, and more
- Work with process owners to facilitate effective processes and continuous improvement
- Maintenance of the Approved Supplier List
- Evaluates, reviews, and approves suppliers’ performance as per required specifications and coordination of supplier audits
- Ensures quality and accuracy in day-to-day activities.
- Attend and conform to end-user security awareness training, organizational information security policies, NDAs, regulatory or contractual requirements.
- Other related duties as required or assigned.
- Post-secondary degree/diploma (or a combination of related education and experience of at least 3 years)
- 0-3 years of related industry experience, preferably in a regulated environment
- Excellent analytical and problem-solving skills
- Able to create and review technical documentation, including project plans, test procedures, and design documents.
- Able to develop, review, and maintain metrics and quality audits.
- Attention to detail and ability to maintain up to date and accurate records
- Knowledge of working with Software Development
- Capable of working well individually as well as part of a team
- Strong communication skills, both oral and written
- Knowledge of Google Office and Microsoft Office productivity suites.
- Strong work ethic and positive team attitude.
- Prior experience working in a SaMD manufacturing environment using Agile development methodology.
Note: This role requires a 5-year job history check.
Who are we? We’re SHOEBOX Ltd. We design and develop audiometry products that are creating a seismic shift in the way hearing healthcare is provided. Utilizing iOS and web technology to replace bulky, expensive equipment, we’re bringing hearing testing into the 21st century and making it more affordable and accessible than ever before.
Why that’s important: 5% of the world’s population suffers from disabling hearing loss, 60% of childhood hearing loss is due to preventable causes, and the majority of people with disabling hearing loss live in low-middle income countries. We can help. With our products, hearing testing can be conducted outside of a sound booth and without the need for clunky equipment (you just need a calibrated headset and an iPad), which allows for testing almost anywhere, anytime, worldwide.
At SHOEBOX, your contribution will have a meaningful impact every single day. On top of that, you’ll be an integral part of an innovative team, working with the latest tools and technologies, pushing the boundaries of what the Quality function can do, and collaborating with colleagues across the company who are super passionate about their crafts.
In joining us, you’re joining a dedicated and passionate team that works hard and cares deeply about the change we’re making in the world. We also take time to celebrate our successes, enjoy lunchtimes together, and genuinely like and care about one another. Also, our founder knows how to do magic tricks. It’s pretty cool.
We offer competitive salaries and benefits, real work-life balance, flexible hours, and a discretionary wellness benefit. SHOEBOX will provide you with a MacBook Air with memory to spare and a 4K monitor.
We invite enthusiastic and qualified applicants to submit their resume by email firstname.lastname@example.org. Please include “Junior Quality Assurance Coordinator” in the subject line.
We thank all applicants; however, only those selected for an interview will be contacted.
SHOEBOX is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.