Job Title: Quality Engineer
Location: North Carolina
Salary: $95k – $105k
Our client takes immense pride is taken in manufacturing world-class products that enhance lives. However, achieving excellence requires an unwavering commitment to quality – and that’s where a dedicated Quality Engineer II comes in. The Quality Engineer II will be the guardian of quality processes, ensuring stringent compliance with ISO and FDA regulations. This challenging role allows for the showcasing of technical prowess while making a profound impact on product quality.
The Impact They’ll Make:
- Drive continuous improvement through quality data analysis and implementation of statistically-sound solutions.
- Conduct in-depth investigations to identify root causes of non-conformances and quality issues.
- Collaborate with cross-functional teams to evaluate new product designs, test methods, and validations.
- Author comprehensive reports, procedures, and specifications with remarkable attention to detail.
- Represent Quality in change control boards, validations, and process improvement initiatives.
- Leverage tools like FMEA, SPC, and design of experiments to mitigate risks.
What They’ll Bring:
- A Bachelor’s degree in an engineering discipline or related technical field.
- 2-5 years of manufacturing experience, preferably in regulated industries like medical devices.
- Extensive knowledge of quality systems like ISO 9001, ISO 13485, and 21 CFR 820.
- Expertise in Lean Six Sigma methodologies and statistical analysis techniques.
- Hands-on experience with CAD/SolidWorks for fixture/product design.
- Exceptional problem-solving abilities to investigate issues and drive sustainable solutions.
- Remarkable technical writing skills to document procedures, reports, and specifications.
- Excellent communication and presentation skills to convey findings persuasively.
This position provides a dynamic work environment that fosters career growth, with competitive compensation and a comprehensive benefits package.
Does this sound like the perfect opportunity to combine a passion for quality with technical and problem-solving capabilities? Then apply directly today, or alternatively email maisncough@kensingtonadditive.com
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