What are the responsibilities and job description for the Quality Engineer - Validation position at Sunrise Systems, Inc.?
Job Title : Quality Engineer - Validation
Job Id : 24-05680
Location : San Diego, CA
Duration : 12 Months Contract[W2]
Position Type : Hourly Contract Position (W2 only)
100% onsite 5 days a week
Job Summary Validation QE II and SR QE(Validation) :
As directed by the Quality Engineering Leader, the Quality Engineer II is accountable validation execution for manufacturing equipment and support in process validation or verification studies.
Successful performance requires close work with quality management, operations, suppliers and / or Client associates to assure compliance with all Client quality policies, procedures, and practices.
Must demonstrate a working understanding of the ISO 13485 Quality Systems Regulations on Class I / II / II products.
Preferred core experience in Quality Assurance, Quality Control, Validation (IQ,OQ,PQ) and Nonconformance management for regulated devices(i.e. : Good Manufacturing Practices, ISO, FDA).
Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.
Education and Experience :
BS Biological Sciences, Chemistry, Bio-tech engineering, Bio-engineering or related field
Minimum of 3-5 years of experience for QE II and 5-7 years for Sr. QE in Medical Device, Biotech or Pharma Industry.
Knowledge and Skills :
Strong verbal and written communication skills; ability to write technical documents. Knowledge of quality system methodologies
Statistical Analysis basic knowledge e.g Minitab or Excel
Strong knowledge of Process Validation and equipment validation
Strong understanding and knowledge on ISO 9001, ISO 14971 and / or ISO 13485 (Design Control, Supplier Management and Risk Management)
Hands on experience using Six Sigma methodology
SAP knowledge
Equipment management system such as BMRAM knowledge preferred
The ability to work in teams and independently with minimal supervision to obtain results as required.
Must be self-motivated / directed, organized, detail oriented and have ability to multi-task projects.
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