Quality Engineer I, QA Systems

Baxter International Inc. • Saint Paul, MN

2d • $76,000 - $104,500

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 at Baxter: As a Quality Engineer, you will provide Quality Engineering support to manufacturing and new product development teams through Engineering Investigations, Qualifications and Validations. In this role you will identify quality issues, participate in quality improvement projects and quality activities that impact manufacturing. Additional responsibilities will include maintenance of on-going stability validations, non-conforming material investigations, maintenance of risk management documentation, and corrective and preventive actions when required. 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 shift. Working together in a supportive and open culture makes our processes evolve for the better and engages our workforce. The role offers competitive salary, and great benefits. Including a 401K and bonuses. You'll be offered extensive training, and the tight-knit working environment within the Manufacturing team means employees get additional training from their direct manager and peers when needed.

Requirements

• BS in Engineering or related field of science.
• 1+ years of experience in Manufacturing Quality, Design Assurance or Quality Systems.
• Experience managing non-conformance activities and owning corrective and preventative actions.
• Must have the ability to read/interpret design prints.
• Working knowledge of FDA GMP and ISO 13485 requirements.
• Knowledge of statistics and quality tools such as SPC, Risk Analysis, Process Capability, DOE, TQM methods, and Lean/Six-Sigma.

Nice To Haves

• Sterilization and Process Validation experience.
• ASQ Certification in Quality Engineering.
• Previous Quality System auditing experience.

Responsibilities

• Responsible for Nonconformance and CAPA activities.
• Investigate and disposition nonconforming materials.
• Initiate, investigate, and implement corrective and preventive actions as assigned.
• Perform internal quality system and supplier audits, as assigned.
• Responsible for site quality support of manufacturing operations including attending Tier Meetings, Engineering Investigations, writing Qualification and Validation plans, statistical analysis of data and preparation of reports.
• Support manufacturing improvements, on-going validations, and new product development efforts.
• Initiate documentation or documentation changes (DCRs, Deviations, etc.) for products and processes as required to reflect validation/qualification activities and results.
• Complaint investigations as assigned by Product Surveillance or Supervisor.
• Support product development teams to develop new products and transfer to manufacturing through participation/leadership of risk management activities, performance of component qualifications, and execution of test protocols.
• Other duties as assigned.

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