Quality Engineer

Baxter • Irvine, CA

13d • $72,000 - $99,000

About The Position

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your Role 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. Your Team Baxter is focused on saving and sustaining lives by manufacturing high-quality products. We strive to create quality products for our customers each day. Delivering life-saving products is about getting them right, and attention to detail is how we make sure we meet that challenge. We are a team that supports each other throughout each day. Working together in a supportive and open culture makes our processes evolve for the better and engages our workforce. What You'll Be Doing Apply sound engineering practices and problem-solving methodology (e.g. Lean & Six Sigma) to arrive at robust and practical solutions in an expedited manner. Act independently with minimal supervision to investigate and analyze process or product issues and design improvement suggestions based on recent technical knowledge. Perform root cause investigation analysis and document within the quality system as appropriate (NCR/CAPA). Design and perform routine testing, project experiments, analysis of data and reports results. 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. Lead product and process improvement & NCR/CAPA projects with minimal supervision, managing cross-functional teams to timely and effective closure. Serve as CAPA Site Representative and Subject Matter Expert (SME) and provide training to local employees as needed on relevant area(s).

Requirements

• 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.

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.
• Apply sound engineering practices and problem-solving methodology (e.g. Lean & Six Sigma) to arrive at robust and practical solutions in an expedited manner.
• Act independently with minimal supervision to investigate and analyze process or product issues and design improvement suggestions based on recent technical knowledge.
• Perform root cause investigation analysis and document within the quality system as appropriate (NCR/CAPA).
• Design and perform routine testing, project experiments, analysis of data and reports results.
• 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).

Benefits

• Baxter offers comprehensive compensation and benefits packages for eligible roles.
• Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees