Quality Engineer

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

Our location in Temecula, CA, currently has an opportunity for a Quality Engineer.

THIS POSITION IS AN ON-SITE DAILY REQUIRED ROLE.

What you'll do:

Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer and provide support to product development teams, helping to ensure development of highest quality new products.

The Quality Engineer is expected to assist in the identification and resolution of quality related issues. You'll have the opportunity to apply subject matter expertise, in an individual contributor role with limited supervision. Expected to provide quality engineering support to the site to ensure manufacturing/quality requirements are met and understand and elevate issues related to quality validations. Work with a team to establish and implement a dynamic structure that fosters and ensures consistent compliance to external laws, regulations, guidances and standards that affect the quality system. The team will develop and follow a process to implement a structure that will facilitate a consistent implementation of external quality system standards including leading activities for site inspection readiness. This structure will improve coordination between functions and increase the awareness and compliance of external requirements.

Core Job Responsibilities

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
• Assist in the review and/or development and execution of streamlined business systems which effectively identify and resolve quality issues
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Lead the investigation, resolution and prevention of product and process non-conformances
• Manages monthly Quality Data Review and/or quarterly Management Review activities for the Site and ensures accurate information is provided at the site level
• Ensures compliance with FDA and global regulatory agency requirements for manufacturing site registrations and device listings
• Lead and Support all site announced and unannounced site inspections/audits from both internal and external agencies, including site preparation/inspection readiness.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• May be responsible for querying & bounding data to support implementation of complex & documenting release criteria.
• Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members. 
• Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development. 
• Assists in creation of Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, and by helping to identify more effective tools & materials.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory require