12 days old

Quality Engineer - Medical Device - great opportunity with growing co.!

Kelly Services
Racine, WI 53408
Kelly has been providing outstanding employment opportunities to the most talented individuals in the marketplace for more than 70 years. We are proud to offer a permanent opportunity for a Quality Engineer in Racine WI. This job is with a growing medical device company and offers competitive pay and great benefits.


+ Develops and initiates standards and methods for inspection and testing.

+ Conducts root cause analysis, analyze failures, and implement corrective action for process-product related concerns and customer complaints.

+ Interfaces with customers to resolve complaints, corrective actions, engineering changes and validation requirements.

+ Performs and analyzes capability studies, gage, R&R, and first article reports on both new and existing products.

+ Facilitates improvements to the Quality Management System via updates to procedures and work instructions stemming from audit findings and continuous improvement initiatives.

+ Works with engineering to coordinate and prepare sample submission packages; updates and maintains process flow diagrams and process control plans.

+ Works with operations on lean and scrap reduction initiatives.

+ Works with Engineering to coordinate and prepare sample submission packages; updates and maintains process flow diagrams and process control plans.

+ Works with Operations on lean and scrap reduction initiatives

+ Works with Engineering and Operations to solve in-house quality concerns, reviews of non-conforming product, recommends disposition and corrective action to prevent reoccurrence.

+ Creates and maintains company quality documentation, such as quality procedures, work instructions and forms.

+ Prepares various quality reports

+ Participates in new project launch teams.

+ Compiles and prepares training material and conducts training sessions on quality control activities.

+ Perform other duties as assigned.

Education Requirements

+ Preferred Associates or bachelors degree in Quality, Engineering, Statistics or technical field with a minimum of three (3) to five (5) years of Quality experience in a manufacturing environment preferably medical manufacturing. Qualifications

+ Experience in Quality Assurance in an ISO or FDA or cleanroom registered manufacturing environment.

+ Sound knowledge of 21CF820 and/or ISO 13485 quality systems.

+ Must have strong working knowledge of Statistical Process Control (SPC) methods using intermediate to advance statistics.

+ Ability to work with mathematical concepts, such as probability and statistical inference and fundamentals of plane and solid geometry and trigonometry.

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

+ Excellent Communication skills written and verbal.

+ High degree of organization and self-motivation.

+ Ability to work in a team environment.

+ Prior experience with an Enterprise Resource Planning (ERP) system.

+ Demonstrated proficiency with Microsoft Office products.

+ Well-organized and task oriented.

+ Must be able to work under pressure and meet deadlines.

+ CQE or CQA preferred.

+ Six Sigma Green Belt certification preferred.

+ Working knowledge of G, D, & T including the ability to read and interpret engineering drawings, schematics and specifications.

**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: 2022-09-23 Expires: 2022-10-24

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Quality Engineer - Medical Device - great opportunity with growing co.!

Kelly Services
Racine, WI 53408

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast