Quality Engineer

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 2-as a team of two with one big idea. Since then, we've grown to over 1,500 employees, sold over 60mm devices, and built a health and fitness community across the globe. In fact, the Fitbit Community has taken enough steps to walk from the Sun to Pluto! Offering award-winning products, a top-rated mobile app and an easy-to-use online 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, onsite workout classes, 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 and around the world. Think you've found your fit?

Brief Description of the Job:

The 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.

Quality Engineer Job Duties:

Supporting Quality Systems based on FDA QSR and ISO 13485
Review Complaints and manage investigations
Support new product development in ensuring compliance with Quality System
Support Risk Management activities including Failure Mode and Effects Analysis
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 Biology/Chemistry/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 2 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.)
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.

Closing Date:
Contact Details:
Contact: Click apply

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