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Quality Engineer

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 site in Temecula, CA is currently looking for a Quality Engineer.

This position is on-site daily required. NO relocation assistance is available for this position.

What Youll Do :

Perform Abbott Vascular quality engineering activities by developing and maintaining data integrity and cybersecurity policy, standards, applications, systems, etc. Work closely with R&D, Equipment Engineering, Quality Engineering and IT on risk identification and mitigation activities. Facilitate cross functional team collaboration to achieve data management goals.

Main Responsibilities :

• Support project planning and perform assessments and mitigations with cross functional teams. Develop and manage training programs including training material and training audience. Track and report metrics.
• Provide support to internal and external audits. Manage relevant audit findings and CAPAs.
• Continuously improve processes to align with current and emerging regulatory and customer requirements and best industry practices. Collaborate with AV key stakeholders, Abbott corporate functional groups and other Abbott business units.
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Independently, or lead a project team to, identify, plan and conduct medium-size assigned projects requiring a combination of conventional and custom risk-managed execution plans and investigations. Manages multiple often concurrent projects.
• Lead technical projects with inter-coordinating elements where problem resolution may involve the application of new methods and / or approaches and may require consideration of impact with other system components and / or users.
• Lead and / or participate on cross-functional teams to support organizational goals.
• Responsible for completing documentation in a timely manner and in accordance with business standards.
• Serve as a subject matter expert (SME) on a subset or select subsets of a projects technical matters. May interface with external firms or agencies.
• Responsible for implementing the effectiveness and maintaining compliance of the Quality System. (e.g. compliance with internal procedures and FDA, BSI regulations etc).
• Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
• Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.
• Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit.
• Assists with evaluating project costs.
• Identifies, develops and implements processes to improve department performance.
• Implements improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research / select new tools based on findings.
• Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.

Qualifications :

Experience / Background

Minimum Education

Bachelors degree (Engineering / Life Sciences) AND 2-5+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience.

Experience

Minimum 2-5+ years. Requires 2-5+ years of quality experience to develop the competence to meet the skills and responsibilities of the position.

What We Offer :

At Abbott, you can have a good job that can grow into a great career. We offer :

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.

Abbott is an Equal Opportunity Employer, committed to employee diversity.