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Baxter International Inc. · 1 day ago

Principal Quality Engineer

St Paul, MN

Full-time

Onsite

Lead/Staff

$104K/yr - $143K/yr

8+ years exp

Baxter International Inc. is dedicated to redefining healthcare delivery and improving lives. The Principal Quality Engineer will provide quality leadership and support for biological and mechanical microsurgery medical devices, ensuring proper product design and manufacturing processes are executed effectively.

BiotechnologyClinical TrialsHealth CareMedical

No H1B

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

Qualification

Quality EngineeringStatistical MethodsRisk AnalysisFDA Quality RegulationsISO-13485ISO-14971MS OfficeMicrobiology ValidationQuality AuditingTechnical WritingLeadership SkillsProblem Solving

Required

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

Preferred

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

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