15 days old

Quality Assurance Engineer

Kelly Services
Los Altos, CA 94023
Kelly Services is currently seeking **Quality Assurance Engineer** for one of our top clients in **Los Altos, CA.**

**JOB TITLE: Quality Assurance Engineer**

**INDUSTRY:** Medical Device

**WORK LOCATION:** Los Altos, CA

**DURATION:** 12 Months (Temporary / Contract)


**What we want:**

o An individual that provides quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes.

o Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers.

o Ensure compliance to regulation and standards.

o Strong understanding of manufacturing process and process control.

o Technical understanding of manufacturing prints and tolerances.

The Quality Assurance Engineer serves a key role for remediation and integration activities for both sustaining and merger & acquisition (M&A) quality support. As a leader in achieving staggering growth through M&A and R&D, continues to set the pace to successfully integrate and bring disruptive technologies to operating rooms all over the world, every day. The Senior Quality Engineer interfaces with many functions of the business, both internal and external, including, sourcing, regulatory, and operations, ensuring that the products and services provided by our global supply base continue to meet and exceed customer needs.

**What you will do:**

o Work closely with operations and the business functions to ensure quality performance of product and processes.

o Develop and implements methods ad procedures for process controls, process improvements, testing and inspection to ensure the products are free of flaws and functions as design.

**Key Areas of Responsibility:**

o Lead quality system maintenance by identifying and correcting deficiencies in procedures and practices.

o Design and/or implement methods and procedures for inspecting, testing and evaluating the precision and reliability of products and/or production and/or test equipment. This includes but is not limited to: Statistical process controls, incoming part/in process, and final inspection criteria, MSA, etc.

o Prepare or modify documentation for inspection/testing procedures.

o Design and/or specify inspection/testing procedures.

o Own identified In-house non-conformances and manage the timely closure of NC's within Trackwise. Own or support identified supplier CAPAs and manage to timely root cause investigation, implementation and closure.

o Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, take action as necessary.

o Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits, establish process parameters, resolve quality problems, etc.

o Analyze and define critical quality attributes for product and process through risk analysis techniques.

o Develop and review of process and equipment validation/qualifications. Build proficiency in validation processes.

o Collaborates with supplier quality for in house supplier quality issues.

o Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.

**What you will need:**

**Basic Qualifications:**

o Bachelors Degree

o 3+ years' experience in quality, engineering, manufacturing, or highly regulated environment

o Good Knowledge GMP, ISO 9001, ISO13485, CFR820 or comparable industry standards and regulatory requirements.

o Computer literacy.

o Good knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment.

Preferred Qualifications:

o Bachelors Degree in Engineering or Science-related field


o Understanding of US, EU and International Medical Device Regulations.

o Strong knowledge of Quality Concepts (e.g. Risk Management, NC/CAPA, Audits, Statistics).

**Why Kelly?**

Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.

As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career

+ Access to more than 3,000 online training courses through our Kelly Learning Center

+ Weekly pay and service bonus plans

+ Group-rate insurance options available immediately upon hire*

**Let us help advance your career today** **.**

**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: 2021-11-12 Expires: 2021-12-13

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Quality Assurance Engineer

Kelly Services
Los Altos, CA 94023

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