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Quality Engineer I
1 month ago
Quality Engineer I (12 month contract // Plymouth, MN):
Top 3 Skills:
- Operations support experience
- Med device experience
- Engaging personality
Primary responsibilities/day to day activities:
- Non-conformance management
- Manufacturing process improvement
- Change Controls and Change Management
- Statistical Analysis, including SPC
Duties:
- 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.
Must Haves:
- Bachelors Degree in Engineering or similar discipline is required
- Candidates should have some previous professional engineering activities, ideally an internship within the Medical Device arena
Nice to Haves:
- Experience with Supplier Quality activities, including component analysis, supplier actions, etc.
- Statistical Analysis experience, including NC/Complaint trending and Statistical Process Controls
- Experience with Material Disposition, NCs and NCRs, and CAPA Ownership
- Experience with Change Control and Change Management Activities
- General understanding of developing risk analysis for Medical Devices
