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11 days old

Quality Assurance Specialist

Kelly Services
Bothell, WA 98021
Kelly Services is currently looking to hire a **Quality Assurance Specialist** to work for one of our top Medical Device clients on-site in **Bothell, WA** . This is an excellent opportunity to work for a renowned company in an exciting industry.


**Quality Assurance Specialist** will perform complaint investigation activities for product complaints and Adverse Events with cross functional team members and provide complaint investigation reports in compliance with procedures, Food and Drug Administration FDA , International Standards Organization ISO , Quality System requirements, and other regulatory guidelines.


+ Works independently to investigate root cause of product related complaints and adverse events in compliance with company procedures.

+ Identifies applicable corrective and preventative actions to facilitate complaint closure.

+ Manages timelines for complaint investigation to ensure that investigations are performed in a timely manner.

+ Develops or contributes to development of quality processes for complaint handling.

+ Provides technical input for adverse event investigations.

+ Perform periodic trend analysis as a Post Market Surveillance early warning system on complaint data.

+ Perform Post Market Surveillance trend analyses.

+ Generate or apply statistical methods with appropriate risk-based justification.

+ Lead or support Post Market Surveillance related projects to improve source data required for Post Market Surveillance activities


**Experience, Education, Training**


+ 4 years bachelor level degree in Science, engineering or other similar discipline.

+ Minimum of 1-3 years of experience within Medical Device Industry is preferred.

+ Technical writing in English required

+ Working knowledge of FDA QSR, ISO 13485:2003 and applicable global regulatory requirements for complaint handling.

+ Working knowledge in risk management for medical devices is required

+ Excellent skills at tracking, trending, analyzing and reporting key quality metrics for complaint history using electronic database systems.

+ Knowledge and experience working with software systems used for complaint handling and/or other relational database experience is preferred.

+ Demonstrated analytical capabilities with the ability to summarize data into graphs, charts and statistics using any software Excel, Minitab, SQL, PowerBI, etc. is required.

+ Basic understanding of programming languages Python, SQL, Java, etc. is preferred.

+ Language and Verbal Skills Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.

+ Math Skills Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

+ Analytical and Reading Skills Ability to read, analyze, interpret and assist in the creation and refinement of company procedures.

+ Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.

+ Ability to calculate figures and apply mathematical concepts like statistics.

+ Work Environment Must be comfortable working in a company environment with rapidly evolving needs, responsibilities and expectations.

+ Safety is committed to the health and safety of our employees.

+ We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.


**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch.

Applicants must be legally permitted to work in the United States immediately and without employer sponsorship. ( **F1 OPT/H1B** cannot be considered for this position).


**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: 2022-08-01 Expires: 2022-09-01

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Quality Assurance Specialist

Kelly Services
Bothell, WA 98021

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