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