QA Engineer

Role : QA Engineer

Location: Irvine CA (Onsite)

Duration: Contract

A minimum of 7 years of experience in Quality Engineering or Quality Assurance including data analysis risk assessment and risk mitigation is required.

Working experience in good manufacturing practice regulated environment is preferred(medical device pharmaceutical etc.).

Under (e.g. limited supervision general direction etc.) and in accordance with all applicable federal state and local laws/regulations procedures and guidelines this position:

Provide timely business support for the assigned CSS Supplier Quality Management (SQM) function globally.

Lead develop and implement supplier/purchasing controls and associated activities including Approved Supplier List management.

Participate in and/or support the identification selection qualification monitoring and disengagement of suppliers for Supplier Quality Management. May lead this process under the guidance of Supplier Quality Manager and/or management representative.

Collaborate with suppliers and business partners to ensure robust materials products processes and systems. Partner with Procurement R&D Engineering/Technical Operations Quality Operations and Suppliers in the timely investigation resolution/prevention of supplierrelated issues to minimize/prevent business disruptions.

Monitor and analyze supplier performance metrics identify areas of opportunity communicate supplier risks and drive the resolution of supplier quality issues and risk control processes.

Implement supplier change management process including change notification

dissemination of information impact assessment approval of changes and supports material/supplier qualifications.

Own drive and lead the assigned Supplier Quality related projects activities initiatives with limited supervision. Utilize Project Management methodologies to plan organize connect shape lead and deliver results for SQM projects.

Apply appropriate Quality Engineering and PEx tools (e.g. PM/VSM Kaizen

DMAIC FMEA/FTA RCA MSA SPC Cp/Cpk/Cpm/Ppk Hypothesis Testing ANOVA/DOE/EVOP etc.) to support innovations and continuous improvements.

Comply with all applicable quality management system environmental safety and occupational health policies. (for example ISO 13485 ISO14001 & OSHAS18001).

Responsible for communicating business related issues or opportunities to next management level.

Take part in making decisions on selection of suitable team based on the project needs in concurrence with the customer

Meet delivery promise in terms of budget and timescales

Monitor project progress and team performance and make necessary changes to the team as needed to ensure achievement of project goals

Work within a multidiscipline team

Responsibility for team and crossfunctional communications; lead phase and business reviews project meeting minutes issues log metrics and other key communications

Quality Management Systems FDA Presentation Strong communication skills ISO 13485 Medical Device Regulatory Standards Quality Compliance CAPA / NC