At Fitbit, our mission is to help people lead healthier, more active lives by empowering them with data, inspiration and guidance to reach their goals.
We started our journey in 2007—as a team of two with one big idea. Since then, we’ve grown to over 1,700 employees, sold over 90mm devices, and built a health and wellness community across the globe. In fact, the Fitbit Community has taken enough steps to walk from the Sun to Pluto and back again! Offering award-winning products, a top-rated mobile app and an easy-to-use dashboard, Fitbit provides personalized experiences that help our users reach their goals. With a reenergized focus on innovative devices, interactive experiences, and enterprise health we are transforming the way consumers and businesses see health & fitness.
From your first steps as a Fitbitter, you will be at the forefront of developing new products. Our culture combines the spirit of startup with the perks of being public. We offer a competitive benefits package and amazing perks like unlimited snacks, Friday happy hours, a wellness stipend, and a strong focus on a healthy work-life balance. As part of our team, you’ll have the opportunity to grow your career, contribute your ideas to life-changing products and services, and—above all—have fun doing it.
Fitbit’s HQ campus is located in the heart of San Francisco with office locations in Boston, San Diego, Salt Lake City and around the world. Think you’ve found your fit?
Brief Description of the Job
The Senior Quality Engineer is responsible for assisting in establishing, implementing and maintaining systems and/or services to measure and improve product quality, cost, and customer service while ensuring full compliance to FDA and applicable ISO requirements. The Quality Engineer will also assist in establishing and monitoring systems related to Inspection, Testing, Training, Supplier Qualification, New Product Introduction, Manufacturing, Complaints, and Corrective/Preventative Action.
- Updating and implementing Quality Systems based on FDA QSR and ISO 13485
- Review Complaints and manage investigations
- Review and manage Corrective and Preventative Actions
- Perform Quality Training
- Support new product development in ensuring compliance with Quality System
- Represent Quality on New Product Introduction Teams
- Manage Design Control deliverables for Medical Device products
- Establish and maintain Design History File for Medical Device products
- Lead Risk Management activities including Failure Mode and Effects Analysis
- Track and manage Quality Improvement projects
- Manage and Support RMA process
- Manage and Support Supplier Qualification
- Available to be on weekly calls in the evening with global contract manufacturers and suppliers in other time zones
- Ability to travel 25% domestically and internationally as needed, sometimes on short notice
Desired Skills and Experience
- BS or MS degree in Mechanical/Electrical/Industrial Engineering
- The Quality Engineer will be innovative, knowledgeable and intensely committed to ensure that products we supply conform to FDA and Quality System Regulations.
- At least 5 years of experience working within the Quality organization of a Medical Device Manufacturer.
- Background in the high tech and consumer electronics desired.
- Experience with domestic and overseas manufacturing and working directly with Contract Manufacturers and strategic vendors
- Experience with product lifecycle management (P/N creation, BoM creation, ECO generation and management, AVL management, etc.)
- Experience with Medical Device product launch and sustaining engineering.
- Quality engineering background and experience with AQLs, product inspections, vendor qualifications and audits
- Proficient in MS Office programs (Word, Excel, PowerPoint), Visio, MS Project; experience with document templates and scientific reference software is desirable.
- Must be detail-oriented with strong written and oral communication skills.
Fitbit is proud to be an equal opportunity employer. We recruit, hire, train, promote, pay, and administer all personnel actions without regard to race, color, ancestry, national origin, citizenship, religion, age, sex (including pregnancy, childbirth, and medical conditions related to pregnancy, childbirth, or breastfeeding), sex stereotyping (including assumptions about a person’s appearance or behavior, gender roles, gender expression, or gender identity), sexual orientation, gender, gender identity, gender expression, marital status, medical condition, mental or physical disability, military or veteran status, genetic information or other statuses protected by law. We interpret these protected statuses broadly to include both the actual status and any perceptions and assumptions made regarding these statuses.
San Francisco applicants: Pursuant to the San Francisco Fair Chance Ordinance Fitbit will consider for employment qualified applicants with arrest and conviction records.