Senior QMS Engineer
Fitbit, US - San Francisco
Stay motivated and improve your health by tracking your activity, exercise, food, weight and sleep
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 1,500 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?
The Senior QMS Engineer is responsible for leading the in establishing, implementing and maintaining systems to measure and improve product quality, cost, and customer service while ensuring full compliance to applicable regulations. The Senior QMS 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. The Senior QMS Engineer will also routinely assess and monitor the effectiveness of the systems and implement improvements as identified.
- Ensuring compliance to the Fitbit Quality System
- Evaluate new and changing federal, state, local and international regulations that impact medical device and wearable operations and communicate changes throughout the organization
- Lead projects to update and implement improvements to Quality Systems based on FDA QSR, ISO 13485, ISO 9001 and other applicable standards.
- Lead the review of Customer Complaints and manage investigations
- Lead Corrective and Preventative Action process
- Managing and executing Internal Audits
- Assess and monitor the effectiveness of the Quality System through metrics and KPIs
- Ability to travel 25% domestically and internationally as needed, sometimes on short notice
Desired Skills and Experience
- Minimum of 8 years of experience working within the Quality
- Experience leading the implementation of a Complaint Management System
- Experience working within the Quality organization of a Medical Device Manufacturer
- Proficient in MS Office programs (Word, Excel, PowerPoint, Visio)
- Must be detail-oriented with strong written and oral communication skills
- Must be a strong influencer across cross-functional teams with proven ability to complete tasks
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.
We're a passionate team dedicated to health and fitness who are building products that help transform people's lives. While health can be serious business, we feel it doesn't have to be. We believe you're more likely to reach your goals if you're encouraged to have fun, smile, and feel empowered along the way.
Want to learn more about Fitbit? Visit Fitbit's website.
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