Title: Software QA Manager
Location: Brookfield, CT
Employment: Full time
About our Company: ROMTech is a 6-year-old medical technology company that has created and patented a revolutionary medical device and telemedical platform which delivers remote rehabilitative care for orthopedic, cardiac, and long-term care patients. Our technology is proven to yield faster recoveries with less pain and better outcomes. Our first pioneer device and platform are complete and now to market. Demand is intense, with orders from more than 700 physicians for 11,000 units already and growing quickly. We are currently fulfilling these orders, and simultaneously scaling up to fulfill the booming demand.
We proudly source the components in our device domestically, making them true “Made In America” products. We aim to design and build products that live up to the historic reputation of the finest American quality, and we seek new members of our team who would like to contribute to this goal.
The company has been well-funded, having raised over $110 million dollars to date. We are in revenue with sales growing quickly, and are now preparing the company for a NASDAQ IPO.
Overview
ROMTech is currently seeking a Software QA Manager to champion the Quality Assurance activities within the software group. You will manage and provide guidance to the QA team, refine the QA process, and ensure that our software meets the quality standards that are required by the business, regulatory bodies and ultimately patients. Your broad knowledge of software quality principles and medical design controls, together with your energy and attention to detail will assure our mutual successes.
Duties and Responsibilities
- Manage, mentor, and guide a team of 3-5+ software QA engineers, focusing on manual and automation testing
- Refine the internal QA process, ensuring compliance with FDA regulations and guidance
- Guide and make improvements to the test automation process
- Work with the Software and Quality teams to continuously improve our QMS to ensure compliance with FDA regulations, as it relates to software
- Participate in the creation, review, and maintenance of the DHFs for our device / system software and firmware
- Participate in, and guide the software risk management activities, including Software FMEA and FTA processes, within the guidelines of the ISO 14971 standard
- Participate in the creation and review of test plans, protocols, test reports and traceability matrices
- Participate in the review of software requirements, design documents and other design control documentation
- Provide software team support for quality system activities such as audits, complaints and CAPAs
- Support the software development team in ways that help improve the initial quality of code
Requirements and Qualifications
- A bachelor’s degree in a software related technical field such as Computer Science, Computer Engineering or Biomedical Engineering
- 4 years of experience in software quality assurance and/or design assurance of FDA regulated medical devices
- Experience with both manual and automated testing methodologies
- Experience working within the IEC 62304 SDLC standard, exposure to Agile methodologies using AAMI TIR45, and Risk Management in accordance with ISO 14971
- Working collaboratively within software teams, demonstrating successful compliance to regulatory standards
- A passion for quality in the medical device field
Preferred Qualifications:
- Experience managing a QA team working with mobile, digital health or embedded software applications for medical devices
- Strong knowledge of the application of regulatory requirements for the different risk levels of medical device software
- Exceptional organizational and communication skills, as demonstrated by independently providing high quality deliverables
- Experience supporting and/or participating in audits by regulatory bodies
- Experience with quality systems software tool validation
We are an early stage, entrepreneurial company. The right candidate will be comfortable working with a small team and have a good balance of “doing things right” (quality, experience) and thinking outside the box / flexibility.
Qualified candidates, please respond and include:
- A cover letter detailing why you are the ideal fit for this position
- An up-to-date resume
Candidates who send resumes without the requested cover letter will not be considered.
Finally, openness, honesty, and candidness are qualities we respond to — as opposed to framing things in the right way with the right words. Please be who you are and let the dice roll.
We are an equal opportunity employer. Qualified Applicants are considered for positions and are evaluated without regard to mental or physical disability, race, color, religion, gender, national origin, age, genetic information, military or veteran status, sexual orientation, marital status or any other classification protected under applicable Federal, State or Local law.