Quality Associate, I (12-months contract)

Baxter International; Mississauga; On-site; CAD 55,000 - 75,000; Full time

Job summary

A global healthcare leader located in Mississauga is seeking a Quality Assurance professional to ensure product quality and compliance with regulations. This role involves oversight of service processes, monitoring product quality, and supporting calibration programs. Candidates should have a Bachelor’s degree and 2-4 years of relevant experience in a regulated environment. Strong analytical and communication skills are essential for success in this position.

Qualifications

• 2-4 years of related experience required.
• Knowledge of Health Canada and FDA regulations preferred.
• Experience in Quality Assurance or Compliance function.

Responsibilities

• Ensure product quality and efficacy through assessments.
• Monitor product quality through inspections.
• Coordinate calibration and preventive maintenance programs.

Skills

Quality Systems experience

Operational compliance

Attention to detail

Analytical skills

Excellent communication skills

Education

Bachelor’s degree in a related field

College Diploma

High School diploma

Tools

Computer systems for documentation

Job description

Overview

This is whereyour work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

Your role with Baxter

This role is responsible for endorsing service processes and ensuring product quality, efficacy, and safety through the routine assessment of service depot operations and finished products. This position will support final inspection and product release activities for Baxter serviced product. Individuals will follow documented standard work instructions and record findings into the system of record. Individuals may also assist other areas of the value stream with packaging and shipment preparation as needed. Additionally, this role will support the maintenance of the calibration and preventive maintenance program to ensure facility and Baxter global requirements are met.

What you will be doing

• Understanding and oversight of service processes and corresponding testing required for depot serviced electromechanical devices.
• Perform final review of documents (e.g. test data, calibration certificates, preventive maintenance results etc.) which includes reviewing for parameters to confirm test results are within specifications, ensuring documentation is completed as per Good Documentation Practices (GDP) and Data Integrity requirements.
• Monitors product quality through the performance of required visual and functional inspection. Release serviced medical devices as per standard operating procedures in a timely manner to meet customer needs.
• Adheres to all environmental, health and safety SOPs, equipment, policies, and procedures, including any department specific requirements.
• Promotes process control through activities in support of equipment and process validations. This includes protocol ownership, paperwork initiation, coordination of service process requirements and performance of required checks.

• Coordinate the Depot Calibration and Preventive Maintenance Program with Service technicians, Quality and External Calibration vendors. This includes requesting quotes for calibration, adjustment and repair and performing inspections and documentation review on the returned instruments prior to their release for service use.
• Ensures the accuracy of measuring and testing equipment through the performance of calibrations and preventive maintenance activities as required.
• Supports the maintenance of Calibration and Preventive Maintenance scheduling database.

• Provide training to new hires or other employees as required.
• Train to new regulations or revised procedures.
• Identify and participate in continuous improvement activities and projects assigned by management.
• Develop and maintain relationship with CTS service/operations and other internal customers (quality, warehouse etc).
• File and maintain documents/records.

What do you bring

• Bachelor’s degree with 2-4 years of related experience; OR College Diploma with 3-5 years of related experience; OR High School diploma with 4-6 years of related experience

• Preferred:

• Bachelor of Science Degree or other technical degree/diploma

• Quality Systems or Operations experience in a Regulated Environment (Healthcare or Pharmaceutical), Service or Manufacturing.

• Background specifically in local Health Canada regulations and FDA requirements related to Medical Device Servicing.

• Minimum 1-3 years work experience in a related industry in a Quality Assurance, Quality Control, Technician or Compliance function.

• Previous experience in a Regulated industry, preferably in Medical Devices.

• Organized and analytical approach.

• Attention to detail and accuracy.

• Excellent written and verbal communication skills.

• Ability to prioritize multiple tasks.

• Strong problem solving and analytical skills.

• Ability to work autonomously.

• Knowledge and application of computer systems for word processing, reporting and data analysis.

• Understanding of Health Canada, FDA 820, cGMP and Medical Device Regulations.

Equal Employment Opportunity

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

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