Sr Quality Engineer
Every day, Baxter touches the lives of millions of patients and providers worldwide who rely on our essential hospital and renal products and services. You’ll find Baxter’s products and therapies on nearly every floor, in almost every hospital worldwide, in clinics and in the home. Baxter’s employees are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. Our commitment to our mission means we are there when patients and healthcare professionals need us, during the critical moments that matter most.
As the successful candidate you will participate in key strategic Quality initiatives and provide technical support and leadership to the Canadian Technical Service (CTS) Quality organization.
In addition, you will be responsible for managing the Quality Management System elements in Technical Service and implementing and evaluating optimal, cost-effective projects and technologies. The incumbent may also perform the following functions: supervising, requisitioning, defining, initiating, documenting and training.
Essential duties and responsibilities:
- Adheres to all environmental, health and safety SOP’s, equipment, policies and procedures, including any department specific requirements.
- Act independently with minimal supervision to manage approved projects
- Performs trend analysis of applicable product or system data. Provide direction or guidance based on analysis results.
- Design and implement improved process systems and initiate new projects, evaluate or justify changes to optimize existing systems.
- Investigate and analyze deviations from the procedures and implement corrective and preventive actions.
- Assess and provide guidance on implementation of process changes.
- Ensure compliance with approved regulatory submission commitments and Baxter policies and procedures; and identify compliance gaps and follow plans to address compliance gaps
- Execute Validation activities required at CTS
- Participate in Enterprise Management System initiatives (Visual KPI boards, daily accountability and Leader Standard Work)
- Develop SOPs and ensure compliance with the SOPs instructions
- Manage and maintain organization of all quality documents at CTS
- Subscribe to current SDLs and documents from BPLM / TcU and verify that all documents at CTS are current
- Ensure that corrective actions are implemented in a timely manner to meet audit and improvement commitments
- Provide support for compiling information for Management Reviews and Audit requirements.
- Support all external and internal audits (including audits by Health Canada, Corporate, ISO and UL)
- Attend to personal development matters such as training (in-class or self-training); team communication meetings, and other related matters
- Provide training to new hires
- Bachelor Degree
- Bachelor in Electronics, Biomedical Engineering, Mechanics
- SIX SIGMA certification
- PMP certification
Major Subjects / Specialties
- Engineering or equivalent
• Biomedical , Electronics
Type of Experience
- Service /Production/Quality/Biomedical
- Understanding of Health Canada GMP and Medical Device Regulations
- Knowledge of products and their intended use.
- Experience in the manufacturing / service environment
- Project Management Planning
Years of Experience
- 3-5 years
- 4-7 years – Quality experience
Additional Skills / Special Training / Technical Skills Required
- Good software application skills
- Able to provide solutions that reflect understanding business objectives and cost implications.
- Excellent written/oral communication and organizational skills.
- Knowledge and application of computer systems for word processing, reporting and data analysis.
- Ability to work autonomously.
- Ability to prioritize multiple tasks.
- Attention to detail and accuracy
- Strong problem solving and analytical skills.
- Team player.
- Ability to handle physical activities such as lifting 35-lb package.
- Knowledge and application of computer systems for reporting and data analysis, inventory, deviations and complaint management systems
- SIX Sigma Green Belt certification
Thank you for your interest and application to Baxter. All applications will be reviewed and those candidates selected for consideration will be contacted directly.
Baxter is committed to creating and maintaining a barrier-free environment for all employees and customers. We believe in integration and equal opportunity and we are committed to treating all people with dignity and respect.