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Baxter International Inc. · 14 hours ago

Quality Engineer

Irvine, CA

Full-time

Onsite

Entry Level

$72K/yr - $99K/yr

1+ years exp

Baxter International Inc. is dedicated to redefining healthcare delivery to improve lives. The Quality Engineer will lead product and process improvement projects, applying problem-solving methodologies and ensuring compliance with quality standards.

BiotechnologyClinical TrialsHealth CareMedical

No H1B

Responsibilities

Lead product and process improvement & NCR/CAPA projects with minimal supervision, managing cross-functional teams to timely and effective closure

Apply problem-solving methodology (e.g. Lean & Six Sigma) to arrive at robust and practical solutions in an expedited manner

Perform root cause investigation analysis and data trending for NCR/CAPA

Manage project documentation in 'TrackWise' system in compliance with Baxter practices and procedures

Perform monitoring of metrics in support of site and company goals and objectives

Support other teams in Investigation of customer complaints or internal events

Act independently with minimal supervision to investigate and analyze process or product issues and design improvement suggestions based on recent technical knowledge

Perform engineering studies on new equipment to determine proper settings, control points, etc. including data gathering during start up and test batches

Work with manufacturing and other functional groups on manufacturing regulatory compliance issues

Write, execute, and develop report for validation activities, including qualification protocols

Perform work assignments within production department that include training, technical support and/or process trouble shooting support

Serve as CAPA Site Representative and Subject Matter Expert (SME) and provide training to local employees as needed on relevant area(s)

Qualification

Lean & Six SigmaRoot cause analysisFDA quality regulationsQuality Management SystemProject managementInterpersonal skillsVerbal communicationWritten communicationTeam collaboration

Required

Understanding of engineering principles in various engineering disciplines related to medical device manufacturing

Bachelor's degree in engineering

1 - 3 years of experience

Demonstrated ability to effectively run projects and direct the activities associated with those systems in regulated environment

Strong command of problem-solving techniques and ability to coach others in their application

Must be able to write clearly and informatively, present numerical data effectively, able to read and interpret written information

Must have strong verbal and written communication skills, documentation practices (cGDPs), be self-motivated and possess strong interpersonal skills

Ability to work collaboratively in a team-oriented environment

Working knowledge of FDA quality system regulations

Working knowledge of Quality Management System

Benefits

Medical and dental coverage that start on day one

Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance

Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount

401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching

Flexible Spending Accounts

Educational assistance programs

Paid holidays

Paid time off ranging from 20 to 35 days based on length of service

Family and medical leaves of absence

Paid parental leave

Commuting benefits

Employee Discount Program

Employee Assistance Program (EAP)

Childcare benefits

Company

Baxter International Inc.

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For nearly a century, we have delivered on our commitment to saving and sustaining the lives of patients, working alongside clinicians and providers around the world.

Founded in 1931

Deerfield, Illinois, USA

10001+ employees