The Principal Quality Engineer will represent the ICU Quality Engineering Department and report to the Quality Engineering Manager. The Principal Quality Engineer is responsible for identifying, owning and driving quality improvements through adherence to established design control processes, quality engineering and documentation practices. The key responsibility of this position is to be proactive, identify and execute actions to prevent future complaints & manufacturing challenges.
This position is 100% onsite at our Sounthington, CT loocation.
Essential Duties & Responsibilities
- Functional area tasks and responsibilities
- Day to day
- Initiate and manage projects
- Own and manage CAPA tasks and deliverables (Corrective and Preventive)
- Consult with Product and Molding Engineers on in-process non-conformances
- Spearhead initiatives for continuous quality improvements
- Network with senior personnel to build successful relationships internal and external to the company
- Area- or plant-wide process quality expert
- Create and edit documents to support Quality
- Work with Product, Manufacturing, and Molding Engineers on qualification activities for new or modified processes and equipment.
- Long term expectations
- Use broad understanding from start to end of the product manufacturing process in the company to drive win-win solutions for both product quality and manufacturing
- Bring clarity of thought, effectively challenge assumptions in a group setting.
- Mentor entry level quality engineers
- Be able to independently lead a team navigating through hurdles, achieve performance, consider input from multiple functional areas & address the problem through a holistic method
- Day to day
Knowledge, Skills & Qualifications
- Mastered knowledge of the Medical Device Industry and FDA QSR regulations
- Substantial knowledge in one or more key process areas: automation, medical-device assembly, controls, etc.
- Understanding of strength of materials, plastic injection molding, fixturing, testing, and process control techniques
- Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.)
- Project management experience preferred
- Solid works to interpret part dimensions, sectional views, conduct mates and build assemblies
- Technical writing competency
Education and Experience
- Bachelor's degree in Engineering or Technology
- Medical Device Experience is a must
- 10 years' experience in the Medical Device or Engineering Industry
- Advanced Degree may substitute for experience
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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