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29 days old

Quality Engineer

Kelly Services
Bothell, WA 98021
**Quality Engineer**


**Principle Responsibilities and Duties:**


**Note:**


+ Works independently to investigate product related complaints and adverse events in compliance with company procedures using designated databases.

+ Assesses the reported issue to ensure it is addressed in the risk documentation and/or product labeling.

+ Evaluates the issue against product and device history to identify root cause and trends.

+ Participates in cross-functional teams to investigate potentially reportable events or those with potential business impact.

+ Manages timelines for complaint investigation to ensure that reporting is performed on time and complaints are addressed in a timely manner.

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

+ Interfaces with internal and external customers and international affiliates.

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

+ Develops summaries for complaints that have previously been investigated.

+ Compiles complaint data and prepares and presents complaint metrics and trend reports in support of Quality Review Board and Management Review.

+ Works with Service to correlate complaint data with field failure data.

+ Generates periodic reports as requested per government agencies and/or Notified Bodies.

+ Provides technical input for adverse event investigations.

+ Other duties as assigned.


**Experience, Education, Training, Traits:**


Bachelors degree in Science or Engineering or equivalent experience


Minimum of 2 years of progressive quality assurance background in medical device manufacturing with specifically hands-on experience with complaint processing.


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.


Basic knowledge and experience working with typical software systems, such as Microsoft Office


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


Proficient with large data sets (e.g., accurate manipulation and summary analyses)


**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.


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


Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the worlds most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, were here to guide you to the next step in your engineering career.


**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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-08-31 Expires: 2022-10-01

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Quality Engineer

Kelly Services
Bothell, WA 98021

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