CrawlJobs Logo
Baxter Logo Baxter · Manufacturing

Sr Quality Systems Engineer

Costa Rica, Cartago · Job Posted April 27, 2026
Apply Position
Job Link Share

Job Description

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

Job Responsibility

  • Own the Complaints, CAPA, Risk Management, Hold and Corrective Actions systems, as well as their critical metrics and participation in local, regional and corporate forums
  • Implement the Internal Audit Program and follow up on corrective and preventive actions
  • Assess the regulatory alignment of processes and systems
  • Ensure they follow applicable directives and standards
  • Coordinate the system for change oversight, making sure changes stay in sync with regulatory requirements
  • Ensure evaluations of complaint samples, manufacturing investigations, and coordination with Product Surveillance within defined timeframes
  • Facilitate root cause analysis and ensure complete documentation in CAPA processes
  • Implement and maintain the risk system, assessing and controlling risks and leading residual risk
  • Ensure the accurate execution of the Hold process and the corrective field actions (FCA)
  • Maintain effective communication with productive areas and lead actions to reduce complaints
  • Plan and implement internal audits, train the audit team, and keep your training program current
  • Coordinate preparation for external audits and ensure timely implementation of corrective or preventive actions
  • Maintain area indicators, communicate deviations, and ensure the plant is up to date with changes in FDA, ISO, or other regulations
  • Review Quality Alerts, 483s and Warning Letters, ensuring the detailed completion of required actions
  • Provide support in GMPs, CAPA and continuous improvement activities and health, safety and environmental programs
  • Ensure ongoing regulatory compliance, leading and communicating changes to FDA, ISO, and other applicable requirements
  • Safeguard compliance during changes to systems or processes and handle the Change Control system
  • Assess regulatory risk through audit information, Quality Alerts, and Field Actions
  • Coordinate gap analysis against international standards and Baxter regulations

Requirements

  • Minimum of 4 years of experience in manufacturing processes, quality systems, regulatory compliance, and GMPs within Baxter or in companies producing healthcare devices
  • Validated knowledge of ISO 9001, ISO 13485, PMD Law, CMDR, MDSAP, CFR 21 and the Manufacturing Maturity Program (CMMI)
  • Validated experience in auditing systems and certification as an Internal Auditor
  • Knowledge and experience in Sterility Assurance
  • University training in Engineering (Production, Industrial, Chemical, Systems, Electrical, Electronics, Electromechanics) or related career
  • Equivalent experience in production environments with Quality Systems in the medical device manufacturing industry

What we offer

  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
Baxter - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Sr Quality Systems Engineer

8 matching positions

Sr. Quality Systems Engineer

Beacon Technologies is seeking a Sr. Quality Systems Engineer for our client par...
Location
Location
United States , El Segundo
Salary
Salary:
Not provided
beacontechinc.com Logo
Beacon Technologies
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 5+ years of experience in systems engineering on compliance systems, or regulatory technology environments
  • Bachelor’s degree in Engineering, Computer Science, Information Technology, or related technical field
  • Understanding of U.S. import compliance requirements related to CPSC, CBP, ACE, and electronic Certificate of Compliance filings are a plus
  • Experience working with integrated systems such as LIMS, data warehouses, and document management platforms
  • Trained in Veeva vault configuration and administration is preferred
  • Proven ability to translate regulatory and business requirements into clear technical specifications
  • Experience working cross-functionally with IT teams, external partners, and business stakeholders
  • Strong communication skills, comfortable leading meetings, training sessions, and discussions with both technical and non-technical audiences
  • Experience supporting external customers or retail partners in compliance-related processes is a plus
  • Project management experience with system implementations or enhancements
Job Responsibility
Job Responsibility
  • Act as the global subject matter expert for Certificate of Conformance (COC) processes related to U.S. imports
  • Own and continuously improve the end-to-end eCOC workflow, including integrations across Laboratory Information Management Sytem (LIMS), Google Big Query (GBQ), and Veeva
  • Partner with IT to define business and system requirements for enhancements impacting COC generation, metadata, test report management, and CSV full message set creation
  • Ensure alignment of system functionality with CPSC Portal and CBP ACE eFiling requirements
  • Collaborate with laboratories to ensure test reports and supporting documentation are accurately generated and transmitted through the system landscape
  • Support retailers performing direct import by gathering their eFiling requirements, providing guidance on CSV file creation, and troubleshooting submission issues
  • Lead business-side project management activities for system implementations, upgrades, and regulatory-driven changes
  • Oversee configuration, testing, validation, and user acceptance testing for eCOC-related system updates
  • Support the Organizational Change Management and training team ensuring training are developed and delivered to internal and external users to understand how to download test reports, generate COCs, and create compliant CSV files
  • Monitor regulatory updates and proactively assess impacts to systems and processes
What we offer
What we offer
  • career advancement opportunities
  • extensive training
  • excellent benefits including paying for health and dental premiums for salaried employees
  • Fulltime
Read More
Arrow Right

Sr Quality Engineer

As a Sr. Quality Engineer with Husco, every day is a new challenge with new prob...
Location
Location
United States , Whitewater
Salary
Salary:
Not provided
husco.com Logo
Husco
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • College Degree in Industrial Operations, Mechanical Engineering, Quality Assurance, or equivalent education required
  • Five (5) years of experience in quality, manufacturing, or product design
  • Effective troubleshooting, problem solving, and organization skills
  • Ability to muti-task and drive critical issues simultaneously required
  • Strong analytical background with demonstrated ability to analyze, explain, and draw logical conclusions from complex operational, financial, regulatory, and/or business data
  • Authorized to work in the United States
Job Responsibility
Job Responsibility
  • Quality Leadership: Relentlessly and urgently drives, monitors, assists, and motivates the pursuit of defect-free performance. Leads, develops, and implements quality and environmental systems through industry and customer audits and certifications. Mentors, supports, and helps the team’s daily activities
  • KPIs and Line Ownership: Monitors, reports, and drives improvements to customer and internal quality metrics throughout- scrap, PPM, FTT, warranty, line returns, and COQ using data-based decision making
  • Internal and External Corrective Actions: Lead customer and internal quality concerns for specific lines. Complete root cause analysis, containment, and drive corrective actions utilizing the Six Sigma DMAIC problem solving approach
  • Serve as an Internal Technical Resource: Support training needs with APQP, problem solving, root cause analysis, process capability, measurement system analysis, and other data analytic techniques
What we offer
What we offer
  • Competitive pay and benefits
  • 100% tuition reimbursement and support for continued learning
  • 401(k) program with company match
  • 3 weeks of paid time off + 12 paid holidays
  • Ample volunteer opportunities
  • Employee-led clubs and sports teams
  • Fulltime
Read More
Arrow Right

Sr. Quality Engineer

We are currently seeking a Sr. Quality Engineer to join our team in Parsipanny, ...
Location
Location
United States , Parsipanny
Salary
Salary:
Not provided
nttdata.com Logo
NTT DATA
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 6+ years of experience in test automation: Selenium/Java/Cucumber/REST Assured (both UI and API automation) or Selenium/.NET/Cucumber/REST Sharp
  • 5+ years of experience in software testing and writing automation scripts using Java, C#, and/or JavaScript/TypeScript
  • 5+ years of experience in designing functional and end-to-end test cases to ensure comprehensive test coverage
  • At least 4+ year of experience using a test automation tool like Selenium/Cucumber/ Java or Selenium/C#.net/Spec Flow/Rest assured or similar frameworks
  • 3+ years of experience in test automation with AMQ,WMQ, Kafka, Couchbase and GCPS
  • 3+ years of experience with OpenShift and Kubernetes
  • Knowledge in Behavior-Driven Design (BDD) principles and the use of Cucumber (or similar) testing frameworks
  • 3+ years experience in at least one of the performance testing tools (Prefer JMeter or ReadyAPI-LoadUI)
Job Responsibility
Job Responsibility
  • Overall Test Management: Oversee test management, traceability matrix, and provide test status reporting
  • Test Automation: Design, develop, and execute test automation frameworks and suites
  • Evaluate and maintain existing manual and automated test cases and procedures
  • Performance Testing: Conduct load and stress tests using enterprise-level automation tools
  • Results Analysis: Interpret test results and prepare comprehensive test reports
  • Collaboration: Participate in project-wide reviews of requirements, system architecture, and detailed design documents
  • Act as the key point of contact for other test engineers with automation needs
  • Environment Management: Manage and maintain physical, virtualized, and simulated test environments
  • Integration and Issue Resolution: Identify and resolve issues arising from integrating application software with other components
  • Code Coverage and Reviews: Assist in reviewing and determining the code coverage of unit tests
  • Fulltime
Read More
Arrow Right

Sr Engineer, Quality

The Senior Quality Engineer provides engineering support to the plant through pr...
Location
Location
United States , Hayward
Salary
Salary:
96000.00 - 132000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Strong technical writing, investigation and communication skills required
  • Experience leading cross-functional teams preferred
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, POMs, Maximo etc.) Familiarity with MINITAB preferred
  • Minimum 3 years of experience in regulated manufacturing environment
  • BS degree required, preferably in Engineering, Engineering Technology/ Microbiology/Chemistry degree may be acceptable depending on experience
  • Applicants must be authorized to work for any employer in the U.S.
Job Responsibility
Job Responsibility
  • Leads or assists in developing and implementing new machines/processes/computer systems and in improvements to existing methods
  • Supports the manufacturing plant through implementation of process improvements
  • Conducts process/financial analysis through conventional methods of ROI, quality trending/tools, MIP measurements and implements/drives improvements
  • Manage small projects (both new and improvement) to include cost, change management, implementation, and validation
  • Leads cross-functional teams
  • Leads ongoing validation and verification programs such as Continuous Process Verification (CPV), Validation Master Plans, Periodic Reviews, Computer Systems Validation, Stability program and Calibration
  • Perform statistical analysis to support Quality and Production
  • Evaluates sampling/ testing/ qualification plans with respect to current quality levels and test methods
  • Accountable for the testing required in conjunction with protocols, in-process risk assessment, and situation appraisal
  • Composes protocols, final reports, studies, experiments and general information reports for use by management
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • 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
  • Fulltime
Read More
Arrow Right

Sr Engineer, Quality

This is where your work makes a difference. At Baxter, we believe every person—r...
Location
Location
United States , Hayward
Salary
Salary:
96000.00 - 132000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Strong technical writing, investigation and communication skills required
  • Experience leading cross-functional teams preferred
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, POMs, Maximo etc.) Familiarity with MINITAB preferred
  • Minimum 3 years of experience in regulated manufacturing environment
  • BS degree required, preferably in Engineering, Engineering Technology/ Microbiology/Chemistry degree may be acceptable depending on experience
  • Applicants must be authorized to work for any employer in the U.S.
Job Responsibility
Job Responsibility
  • Leads or assists in developing and implementing new machines/processes/computer systems and in improvements to existing methods
  • Supports the manufacturing plant through implementation of process improvements
  • Conducts process/financial analysis through conventional methods of ROI, quality trending/tools, MIP measurements and implements/drives improvements
  • Manage small projects (both new and improvement) to include cost, change management, implementation, and validation
  • Leads ongoing validation and verification programs such as Continuous Process Verification (CPV), Validation Master Plans, Periodic Reviews, Computer Systems Validation, Stability program and Calibration
  • Perform statistical analysis to support Quality and Production
  • Evaluates sampling/ testing/ qualification plans with respect to current quality levels and test methods
  • Accountable for the testing required in conjunction with protocols, in-process risk assessment, and situation appraisal
  • Composes protocols, final reports, studies, experiments and general information reports for use by management
  • Routes documents in the Document Management System
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • medical and dental coverage insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • educational assistance programs
  • Fulltime
Read More
Arrow Right

Sr Engineer, Quality

The Senior Quality Engineer provides engineering support to the plant through pr...
Location
Location
United States , Hayward
Salary
Salary:
96000.00 - 132000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Strong technical writing, investigation and communication skills required
  • Experience leading cross-functional teams preferred
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, POMs, Maximo etc.). Familiarity with MINITAB preferred
  • Minimum 3 years of experience in regulated manufacturing environment
  • BS degree required, preferably in Engineering, Engineering Technology/ Microbiology/Chemistry degree may be acceptable depending on experience
Job Responsibility
Job Responsibility
  • Leads or assists in developing and implementing new machines/processes/computer systems and in improvements to existing methods
  • Supports the manufacturing plant through implementation of process improvements
  • Conducts process/financial analysis through conventional methods of ROI, quality trending/tools, MIP measurements and implements/drives improvements
  • Manage small projects (both new and improvement) to include cost, change management, implementation, and validation
  • Leads ongoing validation and verification programs such as Continuous Process Verification (CPV), Validation Master Plans, Periodic Reviews, Computer Systems Validation, Stability program and Calibration
  • Perform statistical analysis to support Quality and Production
  • Evaluates sampling/ testing/ qualification plans with respect to current quality levels and test methods
  • Accountable for the testing required in conjunction with protocols, in-process risk assessment, and situation appraisal
  • Composes protocols, final reports, studies, experiments and general information reports for use by management
  • Routes documents in the Document Management System
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • medical and dental coverage
  • insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • Fulltime
Read More
Arrow Right

Sr. Quality Engineer

In this critical role, you’ll provide quality oversight and technical leadership...
Location
Location
United States , Buford
Salary
Salary:
130000.00 - 149000.00 USD / Year
bhsg.com Logo
Beacon Hill
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in chemistry, Chemical Engineering, Biomedical Engineering, Radiochemistry, Pharmaceutical Sciences, Biological Sciences, or related field
  • A Minimum of 5 years of experience in quality engineering, quality assurance, or validation within regulated environments
  • Experience working with radioisotope production, radiochemistry, pharmaceutical manufacturing, or nuclear materials is REQUIRED
  • Experience supporting Drug Master File (DMF) submissions or pharmaceutical regulatory filings preferred
  • Experience supporting process validation, equipment qualification, and GMP documentation
  • Strong knowledge of cGMP and regulated quality systems (FDA, ISO, pharmaceutical, or medical device)
  • Working knowledge of radiochemistry, radioisotope production, or nuclear materials handling preferred
  • Experience with risk management methodologies, deviation investigations, and CAPA systems
  • Strong technical writing and documentation skills supporting regulated manufacturing environments
  • Ability to translate development activities into compliant production documentation and regulatory support packages
Job Responsibility
Job Responsibility
  • Ensure compliance with 21 CFR Parts 210 and 211 and/or 21 CFR Part 212 where applicable to radioisotope production activities
  • Support implementation and maintenance of quality systems consistent with pharmaceutical cGMP requirements
  • Provide quality oversight for radioisotope production, purification, packaging, and distribution processes
  • Participate in internal audits and regulatory inspections
  • Develop, review, and approve SOPs, batch production records, validation protocols, qualification documentation, and technical reports
  • Ensure production and development documentation complies with data integrity and recordkeeping requirements
  • Support development and maintenance of master batch records and production documentation
  • Lead or support validation and qualification activities for radioisotope production processes
  • Develop and execute validation protocols
  • Support qualification of production equipment, hot-cell systems, and laboratory instrumentation
What we offer
What we offer
  • Career growth opportunities
  • Work on innovative projects with real patient impact
  • Collaborative, mission-driven culture
  • Competitive benefits package
  • Fulltime
Read More
Arrow Right

Sr Quality Engineer

Drive Quality focus into Service Centre Operations to ensure that quality issues...
Location
Location
India , Visakhapatnam
Salary
Salary:
Not provided
alfalaval.com Logo
Alfa Laval
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BE in Mechanical Engineering from reputed institute
  • 4 to 5 years of experience in quality control department from engineering industries, Automotive organizations
  • Knowledge of welding as well as machining processes
  • Analyze process deviations/ root cause analysis and solutions
  • Basic understanding of gauge calibration, MSA, FMEA etc.
  • Implement 5 S in related QA area
  • Maintaining inspection documents for Customers
  • Daily tracking of quality issues/deviations and highlight in meeting, ensure corrective actions
  • Zero inspection errors/inaccuracy during inspection
  • Drive small projects for process improvements
Job Responsibility
Job Responsibility
  • Inspection of Fabricated, Cast/Forged, and Machined Supplier Parts at Receipt Inspection
  • Report quality deviations in database and communicate to suppliers for corrective actions
  • Resolve supplier quality issues on shop floor and ensure corrective actions implemented
  • Conduct product and process quality audits at supplier locations
  • Establish inspection protocols for new service offerings
  • Ensure timely calibration of gauges and instruments
  • Support suppliers in process improvement initiatives
  • Maintain ISO 9001 QMS documentation
  • Perform preliminary and final inspections using applicable gauges
  • Conduct Dye Penetrant (DP) testing including post-cleaning
What we offer
What we offer
  • Interesting and challenging position in open and friendly environment
  • Opportunity to build a global network with different nationalities
  • Work with true impact on Alfa Laval's future success
  • Learning new things every day
  • Diversity, inclusion and equity
  • Pymetrics assessments
  • Fulltime
Read More
Arrow Right