Quality Engineer II

Engineer II

St. Paul, MN (Onsite)

9 Month Initial Contract

Pay: $30-34/hr

Job Description:

As a Quality Engineer, you will provide Quality Engineering support to manufacturing and new product development teams through Engineering Investigations, Qualifications and Validations. In this role you will identify quality issues, participate in quality improvement projects and quality activities that impact manufacturing. Additional responsibilities will include maintenance of on-going stability validations, nonconformance investigations, maintenance of risk management documentation, and corrective and preventive actions when required. What you'll be doing:

• 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.

What you'll bring--

Required:

• 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.

Preferred:

• Sterilization and Process Validation experience.
• ASQ Certification in Quality Engineering.
• Previous Quality System auditing experience.

Education and/or Experience:

• BS in Engineering or related field of science.
• 1 years of experience in Manufacturing Quality, Design Assurance or Quality Systems.