Quality Engineer - Validation - Sunrise Systems Inc
San Diego, CA 92121-1106
About the Job
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)
Sunrise Systems Inc.
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
- 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.
- 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.
- 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.
- Pavan: Pavan.p@sunrisesys.com [732-272-0382]
- Sangeeth: Sangeeth.k@sunrisesys.com [732-272-0281]
Sunrise Systems Inc.
Source : Sunrise Systems Inc