10 days old

Quality Engineer

Kelly Services
Pleasanton, CA 94588
Quality Engineer

Pleasanton, CA

Up to 66 an hour

6 month contract

Major Job Responsibilities:

Supports Design Control and Risk Management Activities, such as:

-Review and approval of Design Changes

-Updates to Design History Files as a result of Design Changes

-Creation of DHF Indexes

-Revision of Risk Management Files (Plans, Reports, FMEAs, Hazard Analyses)

-Provide interpretation, guidance, and training for cross-functional teams regarding qualification, validation, design control, risk management and change control requirements per ISO 13485, 21 CFR Part 820 and ISO 14971

-Review / approve various qualification / validation plan documents, test strategies, test documents, summaries, and certification packages and associated deliverables as appropriate with minimal supervision.

-Compilation, review and approval of quality documents (Policies, Processes, Procedures, templates, formats etc.).

-Support QMS integration activities

-Other duties as assigned


Excellent communication capabilities and teamwork capacities. Proven ability to work in a global environment and on virtual teams.


Must have 4 year college degree; preferably a BS in Engineering or Science.

Minimum of 5+ years of experience in Quality Assurance or related field such as regulated medical device environment. ASQ Certified Quality Engineer preferred.


Works Monday - Friday 8am - 5pm. Onsite minimum 2-3 days/week.

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **?**

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2021-11-19 Expires: 2021-12-20

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Quality Engineer

Kelly Services
Pleasanton, CA 94588

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