Baxter International Inc. · 5 hours ago
Sr. Engineer, Quality Operations
Skaneateles, NY
Full-time
Onsite
Mid, Senior Level
$96K/yr - $115K/yr
4+ years expBaxter International Inc. is a company dedicated to redefining healthcare delivery and making a significant impact on patients' lives. The Sr. Engineer, Quality Operations will be responsible for compliance, validation, and leading investigations and corrective action projects within designated Quality processes to ensure regulatory compliance and product quality.
BiotechnologyClinical TrialsHealth CareMedical
Responsibilities
Lead NCR's, CAPA's and projects related to integration, remediation, or other items within a designated timeline to meet metric requirements through effectiveness checks
Lead value stream monthly reviews of metrics and project status for the area. Decide on next steps and escalations for further review to improve the system, process or procedures
Train and onboard team members to Quality team for operations. Facilitate and coach assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner. Provide mentoring, development and recommendations
Organize, review, and update applicable Quality System Documentation. Support the data integrity initiatives to relevant systems, processes, and equipment
Evaluate all relevant operational data, reports, statistics, and documentation related to assigned investigation processes and projects for product performance and product quality, to generate proactive and timely actions when needed to address a quality issue or improve a process
Assure product compliance to specifications through implementation of inspection criteria and procedures in operation’s processes. Drives quality and manufacturing improvements to ensure our processes are in state of control
Perform root cause investigation analysis and prepare reports, for negative trends of process or product failures or critical characteristics. Document such actions within the quality system as appropriate (NCR/CAPA). Apply standard operating practices and problem-solving methodology
Assist in complaint/field return investigations related to manufactured product. Lead product projects monthly for responsible areas. Analyze returned components, recommend corrective actions, and follow-up on cross-functional team responses and implementation of corrective actions
Lead process improvement projects (scrap reduction, defect reduction, etc.) with little or no guidance
Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation for responsible areas. Provide guidance to other Quality Engineers for their designated areas as required
Ability to provide requirements for change control based on procedural requirements
Qualification
Required
Minimum of a BA or BS in Engineering having a minimum of 4+ years related experience or 2 years related experience w/ an advanced degree or demonstrated performance and increasing responsibility within Quality roles
Prior experience interacting with the FDA and other regulatory agencies a must
Ability to work effectively with multi-department and multi-site teams
Ability to manage and organize complex technical problems
Good written and oral communication skills, excellent attention to details
Strong team leader with management skills and focus on results
Strong scientific analysis and troubleshooting skills
Knowledge of GMP/manufacturing environment and regulatory compliance for the manufacturing of bulk and finished products and current industry standards related to sterilization, cleaning and other validation processes
Preferred
Six Sigma green belt or ASQ CQE certification highly 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.
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.
10001+ employees
H1B Sponsorship
Baxter International Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (15)
2024 (10)
2023 (17)
2022 (18)
2021 (6)
2020 (14)
Funding
Current Stage
Public CompanyTotal Funding
$2.28BKey Investors
German Federal Ministry of Education and Research
2025-12-08Post Ipo Debt· $600M
2021-04-21Grant· $1.81M
2019-05-15Post Ipo Debt· $1.68B
Leadership Team
Andrew Hider
President and Chief Executive Officer
Giuseppe Accogli
EVP & Chief Operating Officer
Recent News
HospitalManagement.net
2026-01-16
Company data provided by crunchbase