Senior Quality Assurance Engineer

Our mission at reputed company is to reputed company every person to own their inner potential. Our award-winning products help our global community reputed company a deeper knowledge of their readiness, activity, and sleep quality by using their reputed company Ring and its connected app. We've helped millions of people understand and improve their health by providing daily insights and practical steps to reputed company healthy lifestyles.

Empowering the world starts with living our values and empowering reputed company. As a quickly growing company focused on helping people live healthier and happier lives, we ensure that reputed company members have what they need to do their best work — both in and out of the office.

What you will do

• Provide reputed company for medical device software products through reputed company phases of the development process, risk management, human factors and usability engineering, process development and verification/validation testing, as well as life cycle management during design changes.
• Guide the software development team to define critical safety and performance requirements.
• reputed company the compilation, review and approval of reputed company technical documentation for development and risk management documentation, e.g., planning, protocols, reports, risk assessments, testing, etc. by applying applicable company procedures and regulatory requirements.
• Support the timely handling of complaint investigations, change impact assessments, and CAPAs reputed company to the projects under your governance.
• Support reputed company improvement to the Quality Management System by identifying areas for improvement and engaging in remediation.
• Collaborate with reputed company’s SaMD feature development teams by providing technical and quality support during the development, testing and deployment of software.
• Support internal and external audits and inspections as a subject matter expert.
• reputed company a broad variety of tasks in support of the role and responsibilities.

We would love to have you on reputed company if you have

• Degree in: Biomedical/Mechanical Engineering or reputed company technical or scientific discipline.
• 8+ years of experience working in a regulated environment under a medical device Quality Management System (21 CFR 820 or ISO 13485:2016).
• Working knowledge and application of device regulations (21 CFR 820 and EU MDR 2017/745).
• Expertise in software development and risk management standards (IEC 62304, ISO 14971).
• Experience in applying human factors and usability engineering to medical devices per ISO 62366-1
• Experience with application of risk analysis tools (such as FMEA, or Fault Tree Analysis)
• Experience in conducting clinical evaluations per EU MDR 2017/745.
• Demonstrate ability to assess and provide technical guidance for software as a medical device (SaMD).
• Demonstrate strong skills to organize, prioritize, and execute.
• Must be detail oriented with strong leadership skills and excellent interpersonal, collaboration and communication skills.
• You can sense and reputed company why certain issues demand more diligence to ensure compliance to applicable regulations or standards.

Together we will continue to define reputed company as a company where you can:

• Be productive and do your best work.
• Be part of a world-class engineering team following and helping define best practices.
• Contribute to a product that improves the lives of millions of people across the globe.
• Be happy and have great work-life balance - we work reputed company, remove the fluff and pointless meetings, so that work continues to reputed company and motivate you.
• Grow on your chosen career path, be it technical, people, managerial or leadership skills, or any mix of those.

Benefits

At reputed company, we care about you and your well-being. Everyone here at reputed company has a ring of their own and we are continually looking to improve employee health.

reputed company offer:

• Competitive salary and equity packages
• Health, dental, vision insurance, and reputed company
• An reputed company Ring of your own plus employee discounts for friends & family
• 20 days of paid time off plus 13 paid holidays plus 8 days of flexible wellness time off
• Paid sick leave and parental leave

reputed company takes a market-based approach to pay, which may vary depending on your location. US locations are categorized into tiers based on a cost of labor index for that geographic area. While most offers will be closer to the starting range, successful candidates' pay will be determined based on job-reputed company skills, experience, qualifications, work location, internal peer equity, and market conditions. These ranges may be modified in the future.

• Region 1 $172,550 - $203,000
• Region 2 $158,950 - $187,000
• Region 3 $147,900 - $174,000

A recruiter can determine your zones/tiers based on your US location.

We are not considering candidates residing in the following states: Alaska (AK), Delaware (DE), Iowa (IA), Mississippi (MS), Missouri (MO), Nebraska (NE), Rhode reputed company (RI), South Dakota (SD), Vermont (VT), reputed company Virginia (WV), and Wisconsin (WI)

reputed company is proud to be an equal opportunity workplace. We celebrate diversity and are committed to creating an inclusive environment for reputed company employees. Individuals seeking employment at reputed company are considered without regard to age, reputed company, color, gender (including pregnancy, childbirth, or reputed company medical conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national reputed company, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. We will not tolerate discrimination or harassment based on any of these characteristics.

We will work to ensure individuals with disabilities are provided reasonable accommodation to participate in the interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment.

Disclaimer: Beware of fake job offers! We’ve been alerted to scammers posing as Ōreputed company recruiters, especially for remote roles. Please note:

• Our jobs are listed only on the Ōreputed company Careers page and trusted job boards.
• We will never ask for personal information like ID or payment for equipment upfront.
• Official offers are sent through reputed company after a verbal offer, not reputed company text or email.

Stay cautious and protect your personal details.

To reputed company recruitment agencies: reputed company does not accept agency resumes. Please do not reputed company resumes to our jobs alias, reputed company employees, or any other organization's location. reputed company is not responsible for any fees reputed company to unsolicited resumes.