Job Title - Quality Engineer II - Exempt
Job Location - Minneapolis, Minnesota, United States of America, 55432-3568
Duration:-12 Months
Must Have
- 2-5 Years Experience in Quality with BS in Engineering
- Manufacturing Quality Engineer II
- Basic understanding of 21 CFR 820 and experience working in the Medical Device Industry
- Quality
- Strong suppliers change control experience
Nice to Have
- A bachelor’s in mechanical or electrical engineering with ability to build custom fixtures. Ability to read drawings, BOMs, GD&T. Experience in mechanical assembly and components. Ability to work with vendors on dimensions and order components. Ability to qualify equipment in medical device mfg. assembly line. Experience in working in a med device company in a cleanroom environment.
- Ability to effectively facilitate team meetings, create and deliver presentations, and drive meetings to action-oriented decisions
- Ability to use statistical techniques to analyze data capable of developing/reviewing/approving test plans and reports experience in medical devices manufacturing Interpersonal Skills investigate and collaborate in the investigation of atypical events to support product disposition PFMEA
- CAPA Process
- Design Failure Mode and Effect Analysis (DFMEA)
- Manufacturing Process Controls
- Non-Conformance
Job Description
Responsibilities may include the following and other duties may be assigned.
- Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
- May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
Sushma.K
sushmak@grovetr.com
690-357-0907
