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Quality Associate II

Req #: JR - 067569 Location Mississauga, Ontario, Canada Job Category: Quality Control Date Posted: 04/28/2022

Overview

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.

  • Support for Parents

  • Continuing Education/
    Professional Development

  • Employee Health &
    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

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Quality Associate II

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Your Role:

In this role, you will support the UCAN Quality Lead and Service Operations Organization to ensure quality compliance for a region. You will oversee critical projects, whether through leading or quality input. You will be required to functionally understand Health Canada and ISO standards/regulations along with intimate knowledge of Baxter Quality systems, in order to serve as a subject matter expert in quality compliance and partner cross functionally to solve complex problems.

What you’ll do:

  • Partners with Service Operations as a Subject Matter Expert to ensure successful implementation and compliance of procedures / regulations for CTS
  • Monitors quality system compliance for CTS
  • Provides quality support for multiple service centers and field service personnel
  • Supports and leads (where appropriate) activities in achieving annual quality goals in an efficient, accurate and timely manner.
  • Writes, reviews, analyzes and revises written procedures as needed to meet Corporate, Service, Regulatory Requirements, etc. Ensures periodic reviews are conducted on-time.
  • Supports or may lead process/product improvement projects.
  • Leads audit ready status efforts and ensure potential auditees have a general understanding of Health Canada, ISO and Baxter quality requirements. Maintains a high level of expertise in current regulatory requirements.
  • May assist in the validation process of equipment, product changes and computer systems.
  • Act independently with minimal supervision to manage approved projects
  • Adheres to all environmental, health and safety SOP’s, equipment, policies and procedures, including any department specific requirements.
  • Performs trend analysis of applicable product or system data. Provide direction or guidance based on analysis results.
  • Investigate and analyze deviations from the procedures and implement corrective and preventive actions.
  • Monitors compliance to equipment calibration and maintenance requirements, and may assist in risk analysis of nonconformance equipment
  • Assists with service vendor evaluation, re-evaluation and monitoring.
  • Ensures corrective actions assigned to Service are implemented in a timely manner to meet audit and improvement commitments.
  • Provide support for compiling information for Management Reviews
  • Support all external and internal audits (including audits by Health Canada, Corporate, ISO and other regulators)
  • 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

What you’ll have:

  • B A Bachelor's Degree in science, technical, engineering, or related field
  • 3+ years of experience in quality with a medical device or other regulated industry is preferred.
  • Understanding of Health Canada's GMP and Medical Device Regulations
  • Able to provide solutions that reflect an understanding of business objectives and cost implications.
  • Excellent written/oral communication and organisational skills.
  • Ability to work autonomously along with the ability to prioritise multiple tasks.
  • Good software application skills
  • Attention to detail and accuracy
  • Strong problem solving and analytical skills.
  • Team player

Nice to have:

  • 6+ years of experience in quality with a medical device or other regulated industry
  • Prior experience in manufacturing / service environment and audit techniques
  • Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
  • Good project management skills

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

067569

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Christelle

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Lorena

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

Gary

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Christelle

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Lorena

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Gary

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

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