Job Description

About the Company

Kelly Engineering is seeking a Supplier Quality Engineer for a long-term hybrid contract at one of our Global Medical Device clients located in Irvine, CA . Our Client is a global leader in the science of diagnosing and treating heart rhythm disorders. The company partners with clinicians to develop innovative technologies that improve the quality of care for arrhythmia patients worldwide. This role is a full-time, hybrid contract, fully benefited position. As a Kelly employee, you will be eligible for Medical & Dental 50% paid, 401K and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation and sick/personal time. All KellyOCG employees receive annual performance reviews.

About the Role

The individual will be responsible for supporting Cost Saving Projects. This individual will actively collaborate with Product Management, Strategic Sourcing/Procurement, Component Qualification Engineers, Quality, business partners/stakeholders, and external suppliers to support clients' saving projects.

Responsibilities

• Participate in and/or lead the identification, selection, qualification, monitoring, and disengagement of suppliers for Supplier Quality Management .
• Perform due diligence assessment for selected suppliers if needed.
• Prepare Supplier Quality Agreements and drives discussion with supplier while consulting Supplier Quality Manager.
• 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.
• 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.
• Support component qualification in collaboration with key business partners and the supplier's applicable functional groups.
• Comply with all applicable quality management system, environmental, safety and occupational health policies. for example, ISO 13485, ISO14001 OSHAS18001 .
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Qualifications

• A minimum of a bachelor's degree in Engineering, Applied Science or a related technical and quality field is required.
• A minimum of 5-6 years of experience in Supplier Quality Engineering, Quality Assurance, including data analysis, risk assessment and risk mitigation, is required.
• Working experience in a good manufacturing practice regulated environment, medical devices/Pharma etc. is required.
• Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA systems and investigations, laboratory controls, production and process controls, is required.
• Experience with documentation and technical writing skills, in a regulated compliance environment is required.
• Component Qualification/Process Validation experience is preferred.
• New product introduction experience is desired.
• Broad knowledge of Quality System Regulations and Supplier Quality Management principles is desired.
• Demonstrated ability to identify compliance risks and assess business impact is required.

Required Skills

• Working knowledge of regulatory compliance requirements. Quality System Regulations QSRs, Medical Device Directive MDD, ISO 9001, ISO 13485, ISO 14971 or other international standards are required.
• Working knowledge of Quality issue investigation, Non-Conformance Reports NCRs, Corrective and Preventive Actions CAPAs preferred. ASQ Certifications for Certified Quality Engineer CQE, Quality Manager CQM, and/or Supplier Quality Professional CSQP.
• Strong analytical skills, metrics development and ability to identify trends are desirable. Knowledge of specific business practices and software applications skills Word, Excel, PowerPoint, Minitab.

Preferred Skills

This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States immediately and without employer sponsorship. Not accepting C2C, H1B Visa right now.

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