Quality Engineer
Location: Irvine, CA 92618
Duration: 24 months

Pay rate: 38.21/hr on W2

The Quality Engineer I is responsible for working with the Quality, Manufacturing and MS&T Engineering teams to support activities during the overall product life cycle of the assigned product groups. The QE I will support continuous improvement projects, quality issue resolution, Non-conformances/CAPAs, and process controls.

Investigate and/or provide input on non-conformance events (NC) and Corrective Actions and Preventive Actions (CAPA).

Will lead mixed product events and will perform quality approvals on minor nonconformance events.

Track and trend NC and CAPA data with guidance using various statistical and non-statistical problem-solving tools as part of analysis.

Lead (primary) and support the reduction of recurring nonconformance events, reprocessing events, and scrap.

Uses various statistical and non-statistical problem-solving tools as part of analysis of data, issues, or improvement opportunities. Will have minimal statistical (including sampling) knowledge.

Will support escalation events. Support product hold events and quarantine when necessary.

Will author and execute change controls.

The QE I will be required to lead small size projects. The QE I will have minimal project management knowledge.

The QE I will support internal & external audits.

Responsible for the maintenance of product line visual standards and ensuring they are up to date.

Perform capability assessment of suppliers within assigned commodity using incoming inspection or supplier process data to develop a reliable supply chain of quality components.

Support supplier approval and reassessment activities within assigned commodity including, but not limited, to supplier approval surveys, risk assessments, and onsite audits.

Ensure supplier related quality issues (i.e. customer complaints, non-conformances) with assigned commodity are corrected to prevent recurrence.

Involving partnering with the supplier on the use of root cause analysis tools paired with a formal corrective action process.

Execution of GxP Audits worldwide.

Provides a high level of service to client internal customers (Procurement, MS&T, R&D, and site level QA).

Supports, manages and partners with suppliers on projects to meet business requirements such as capacity increases or cost saving initiatives.

Ensures that appropriate client QS requirements are implemented at the suppliers within assigned commodity.

Provide data to maintain metrics for Vendor performance utilizing the different APD databases.

Complete GAP analysis against local, global, and industry standards, as needed, and support development/execution of actions to close gaps under minimal guidance

Preferred Skills:
? Fluent in English
? 1 - 3 years experience in industry. Medical device, consumer, automotive, and aerospace preferred.
? Preferred 1 - 2 years experience in new product introductions/quality/manufacturing/ manufacturing science and technology/technical development/R&D.
? Understanding of manufacturing processes and related process equipment.
? Working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
? Preferred 1 - 2 years of experience in executing process validation, transfer of products from R&D into manufacturing, and working on multidisciplinary teams that include all functions in the manufacturing environment.
? Experience working in a cross-functional environment (e.g. multi-site, technical development, other functions).

Required Education:
BSc. in Engineering (Preferred Mechanical, Electrical, or Manufacturing)