Engineer II

Immediate need for a talented Engineer II. This is a 09+ Months Contract opportunity with long-term potential and is located in St. Paul, MN (Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID:25-64958

Pay Range: $32 - $33/hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
 
Key Responsibilities:

• Responsible for NCR and CAPA activities. Investigate and disposition nonconforming material reports (NCR events). Initiate, investigate, and implement corrective and preventive actions as assigned.
• Perform internal quality system and supplier audits, as assigned.
• Responsible for preparation of written Engineering Investigation, Qualification and Validation plans, statistical analysis of data and preparation of reports to support manufacturing improvements, on-going validations, and new product development efforts.
• Support product development teams to develop new products and transfer to manufacturing through participation/leadership of risk management activities, performance of component qualifications, and execution of test protocols.
• Responsible for coordination of validation activities performed by outside contract services to ensure adherence to specifications and expectations.
• Initiate documentation or documentation changes (DCRs, Deviations, etc.) for products and processes as required to reflect validation/qualification activities and results.
• Other duties as assigned.

Key Requirements and Technology Experience:

• Skills-Quality Engineering, FDA, ISO.
• Experience managing non-conformance activities and owning corrective and preventative actions.
• Must have the ability to read/interpret design prints.
• Working knowledge of FDA GMP and ISO 13485 requirements.
• Knowledge of statistics and quality tools such as SPC, Risk Analysis, Process Capability, DOE, TQM methods, and Lean/Six-Sigma.
• Sterilization and Process Validation experience.
• ASQ Certification in Quality Engineering.
• Previous Quality System auditing experience.
• BS in Engineering or related field of science.
• 1+ years of experience in Manufacturing Quality, Design Assurance or Quality Systems.

Our client is a leading Healthcare Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
 
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