Senior Manufacturing Quality Engineer - Katalyst Healthcares & Life Sciences
Irvine, CA 92602
About the Job
Responsibilities:
- A minimum of 2-4 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 supplier-related 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 multi-discipline team? Responsibility for team and cross-functional communications; lead phase and business reviews, project meeting minutes, issues log, metrics, and other key communications.
Source : Katalyst Healthcares & Life Sciences