Quality Engineer

Abbott; Temecula (CA); On-site; USD 61,000 - 123,000; Full time

Benefits offered by this job

Career development

Health coverage

Retirement plan

Job summary

Abbott Vascular in Temecula, CA is seeking a Quality Engineer to provide process/quality engineering support on the manufacturing line and with product development teams. The role emphasizes CAPA execution, audits, and aligning processes with FDA and industry standards.

You will lead cross-functional initiatives, ensure documentation quality, and drive improvements in quality tools and systems. Onsite work with collaboration across Abbott stakeholders.

Qualifications

• Bachelor's degree in Engineering or Life Sciences required
• 2–5+ years related work experience in quality/engineering functions preferred
• Experience with CAPA, audits, and quality systems is desirable

Responsibilities

• Support manufacturing line with process/quality engineering activities
• Assist with internal and external audits and CAPA closure
• Improve processes to meet regulatory and customer requirements
• Lead or participate in cross-functional project teams
• Ensure timely documentation according to business standards
• Serve as SME on technical matters and interface with external partners

Skills

CAPA experience

Problem solving

Documentation

Quality systems

Education

Bachelor's degree in Engineering/Life Sciences

Job description

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 115,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to :

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

Our location in Temecula, CA, currently has an onsite opportunity for a 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

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

What You’ll Work On

• 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 project's 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.
• Implents 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.

Required Qualifications

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

Preferred Qualifications

• CAPA experience
• Strong technical knowledge and application of concepts, practices and procedures.
• Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors.
• Ability to form and develop interpersonal, professional relationships.
• Display socially and professionally appropriate behavior.
• Ability to work independently and in groups.
• Ability to work cross-functionally.
• Demonstrated initiative and problem-solving skills.
• Critical-thinking skills.
• Ability and aptitude to use various types of databases and other computer software.
• Ability to prioritize.
• Strong organization and project management skills.
• Demonstrated competency with financial systems and in fiscal controls. Ability to quickly gain knowledge, understanding or skills and is willing to learn.

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives : www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.