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Baxter International Inc. · 10 hours ago

Senior Quality Engineer

St Paul, Minnesota

Full-time

Onsite

Mid, Senior Level

$88K/yr - $121K/yr

3+ years exp

Baxter International Inc. is committed to redefining healthcare delivery and making a meaningful impact in the lives of individuals. The Senior Quality Engineer will provide quality engineering support to manufacturing and new product development teams, focusing on quality investigations, validations, and process improvements.

BiotechnologyClinical TrialsHealth CareMedical

No H1B

Responsibilities

Responsible for preparation of written Engineering Investigation, Qualification and Validation plans, statistical analysis of data and preparation of reports to support manufacturing improvements, on-going validations, and new product development efforts

Provide quality engineering support for manufacturing lines, including floor support

Investigate and disposition nonconforming material reports (NCR events)

Initiate, investigate, and implement corrective and preventive actions as assigned

Provide quality engineering support for material nonconformances including supplier corrective actions

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

Responsible for coordination of validation activities performed to ensure adherence to specifications and expectations

Initiate documentation changes and/or change control for products and processes as required to reflect validation/qualification activities and results

Perform internal quality system and supplier audits, as assigned

Complaint investigations assigned by Product Surveillance or Supervisor

Participate in, or lead, Kaizen or other Lean 6-sigma problem solving projects

Other duties as assigned

Qualification

Quality EngineeringFDA GMP knowledgeISO 13485 knowledgeStatistical analysisLean/Six-SigmaTechnical writingCuriousMS WordMS ExcelMS ProjectSterilization experienceProcess Validation experienceASQ CertificationQuality System auditingProblem solvingOrganizational skillsCommunication skillsSelf-motivated

Required

BS in Engineering or related field of science

3 - 5 years of experience in Manufacturing Quality, Design Assurance or Quality Systems

Excellent oral and written communication skills

Strong problem solving, technical writing and organizational skills

Self-motivated worker, persistent, curious

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

Working knowledge of MS Word, Excel, and Project applications

Display a solid technical understanding of engineering principles and procedures

Preferred

Sterilization and Process Validation experience

ASQ Certification in Quality Engineering

Previous Quality System auditing experience

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.

Glassdoor3.7

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