Quality Engineer - 2nd Shift

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

Benefits offered by this job

Medical coverage

Retirement plan

Tuition reimbursement

Job summary

Abbott in Temecula, CA is seeking a Quality Engineer for the 2nd shift in the Vascular division, an onsite role. You will provide process and quality engineering support to manufacturing and product development to ensure the highest quality products reach customers.

The role emphasizes CAPA, data analysis, risk management, and adherence to quality systems, with expectations to lead process improvements and collaborate across teams within a regulated medical devices environment.

Qualifications

• Bachelor's degree in a related field with 2–5 years of experience.
• CAPA experience, data analysis and risk management skills.
• Familiarity with medical devices quality systems.

Responsibilities

• Provide process and quality engineering support to manufacturing to ensure high-quality products.
• Support product development teams to deliver quality new products.
• Identify and control manufacturing defects and implement corrective actions.
• Develop quality plans, specifications, and release criteria with the team.
• Create risk analyses and FMEAs as part of quality improvement.
• Lead process monitoring and data analysis to reduce variation and defects.
• Contribute to quality tools and training materials for the site.

Skills

CAPA

Data Analysis

Risk Management

Quality Systems

Education

Bachelor's degree or Master's in a related field

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 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Job Title

Quality Engineer – 2nd Shift

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 of which you dream.
• 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

We are seeking a Quality Engineer for 2nd Shift in ourVascular division. This is a fully onsite role.

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

What You’ll Work On

Provide Process/Quality Engineering support to manufacturing, 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.

Core Job Responsibilities

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Identifies and controls Manufacturing process defects (scrap, nonconforming material, custom complaints) by participating in efforts/teams focused on identifying the primary root causes and
• implementing corrective and preventative actions.
• 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.
• May be responsible for creating risk analyses and FMEAs.
• Develops Process Monitoring Systems by identifying critical process steps applying methods to reduce process variation in order to reduce/eliminate the cause of defects.
• 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.

(Supervision Received) Works under general supervision. Follows established procedures. Work is reviewed for soundness of technical judgment, overall adequacy and accuracy.;

(Supervision Provided) May provide limited work direction and guidance to exempt and/or skilled nonexempt levels of employees; may be asked to evaluate performance of and assist in career development planning for subordinates.

(Influence/Leadership) Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks. May lead a project team of moderate scope. Provides guidance to less experienced staff. Acts as a mentor to lower-level individual contributors. Influence exerted at peer level and occasionally at first levels of management.

(Planning/Organization) Plans, organizes, and prioritizes own daily work routine to meet established schedule.

(Decision Making/Impact) Exercises authority and judgment within defined limits to determine appropriate action. Failure to achieve results or erroneous decisions or recommendations may cause delays and result in the allocation of additional resources.

(Cognitive Skills) Works on problems of diverse scope where analysis of data requires evaluation

of identifiable factors. Exercises judgment within generally defined practices and policies in selecting

methods and techniques for obtaining solutions. Has a sound knowledge of various technical alternatives

and their impact.

(Technical/Business Knowledge (Job Skills)) Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.

Will perform this job in a quality system environment. Failure to adequately perform tasks can result in a noncompliance with governmental regulations.

Education and Experience you’ll bring

• Bachelor's degree plus 2-5 years of related work experience with a good understanding of specified functional area, or Master's degree with 0-2 years of related work experience, or an equivalent combination of education and work experience.
• CAPA experience
• Data Analysis experience
• Risk Management experience
• Experience working with Quality Systems

Preferred Experience

• CQE Certification a plus
• Medical Devices experience preferred

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 and @AbbottGlobal.

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.

JOB FAMILY:

Operations Quality

DIVISION:

AVD Vascular

LOCATION:

United States > Temecula : Building E - TE

WORK SHIFT:

Standard

TRAVEL:

Yes, 5 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf