Principal Quality Engineer

Baxter International Inc. • Saint Paul, MN

2d • $104,000 - $143,000

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 Provide Quality Leadership and support to the value stream product teams for biological and/or mechanical microsurgery medical devices. Ensure proper product design and manufacturing process design and execution for such devices. What You'll Be Doing Participate on product development teams to improve current marketed products and transfer of the design to manufacturing.

Requirements

• B.S. degree in Engineering, or related scientific discipline. ASQ CQE certification is required if 4-year degree is not in engineering.
• 8-10 years of experience in quality and/or product development.
• Job experience or advanced training and demonstrated proficiency in total quality management, statistical methods, qualification of injection molding tools, root cause analysis / resolution, risk analysis, SPC, MSA, and design of experiments.
• Experience in new product development, materials science, and biocompatibility.
• Excellent oral and written communication skills.
• Strong problem solving, technical writing, organizational, leadership, and interpersonal skills.
• Successful track record of leading large or complex projects and diverse teams.
• Working knowledge of FDA Quality System Regulations, ISO-13485, and ISO-14971.
• Technical writing skills
• Proficient MS Office skills including MS-Project and Visio.
• Must have the ability to read/interpret design prints.

Nice To Haves

• Advanced technical degree preferred.
• ASQ Certification in Quality Engineering and/or Auditing is highly desirable.
• Prior supervisory experience.
• Microbiology and sterilization validation experience is highly desirable.
• Experience with biological products and/ or chemical processing is highly desirable.
• Previous Quality Auditing experience is desirable

Responsibilities

• Participate on product development teams to improve current marketed products and transfer of the design to manufacturing.
• Participate in risk management activities (quality planning, product and process risk assessment and risk management), review and approval of process and product validation protocols and reports, review component qualifications, and test method development/validation.
• Lead site initiatives to implement robust validation programs such as visual and mechanical in-process inspection programs, process validation, and test method validations.
• Set statistically valid inspection requirements, including identifying test methods and sampling plans and assisting with designing inspection fixtures.
• Assure measurement systems are capable using MSA, when applicable.
• Partner with manufacturing on quality related process improvement projects, lean manufacturing projects, and equipment qualification/validation, through review and approval of protocols and reports.
• Investigate, analyze, review and report on Product Complaints (Field Events).
• Participate on and lead process improvement teams to implement quality improvement activities using Lean, and Six-Sigma methods.
• Be the site lead to implement systems and processes for global alignment
• Lead or participate in Corrective and Preventive Actions (CAPA).
• Ensure alignment of site processes to business-wide processes.
• Manage coaching, training and development of subordinates.
• Work with external suppliers (injection molding, stamping, and medical assembly).
• Own nonconformances, Corrective and Preventative Action records

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: Mid Level
• Number of Employees: 5,001-10,000 employees