Job Title - Quality Engineer II
Location - San Diego, CA
Duration – 5+ Months
Work hours: 8am-5pm, 40 hours/week
Client: Medical Device Company
Job Category: Engineering
Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)
Both onsite and remote, must be local
3 Must haves on the resume: must haves are hard. Not sure if this what you are looking for:
1) experience in an ISO 9001 or ISO 13485 environment
2) Nonconforming Product or Customer Complaint experience
3) Ability to multitask and work semi-independently
As directed by the Quality Engineering Leader, the Quality Engineer II is accountable for supporting new product development and/or product sustaining activities through the application of Quality engineering skills for medical devices. For Sustaining Product activities, this person will understand, improve, and control operational processes in order to realize predictable product flow while satisfying established BD standards of quality. Successful performance requires close work with quality management, operations, suppliers and/or BD associates to assure compliance with all BD quality policies, procedures, and practices.
Responsible for reviewing, assessing and coordinating Quality Notifications and Deviations for the Reagents plant. Provides critical quality engineering direction with respect to generally accepted quality engineering tools/principles, such as root cause analysis, FMEAs, risk mitigation, CAPA and validations. Conducts complaint investigations to identify Root Cause, assists in the investigation of manufacturing issues and provides data and input on technical issues and projects.
BS or BA in related field required with 2 years of experience, or MS with no experience required. Life Sciences degree, Professional Quality certification (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.) and SAP ERP experienced preferred.
A practical and working understanding of the pertinent Quality Systems Regulations (i.e.: Good Manufacturing Practices, ISO9001 and ISO 13485).
Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.
Capable of using Microsoft programs and ability to learn other systems.
Working knowledge of statistical methods as well as statistical application software.
Effective verbal and written communication skills.
Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects.
The ability to work in teams and independently with minimal supervision to obtain results as required.
Performs other duties as assigned.
Keywords: ISO, 9001, 13485, Quality Engineering, product, medical devices, FMEAs, CAPA, validations, CQA, CQE, Six Sigma, Manufacturing, GMP