Quality Specialist - Product Surveillance (14 months contract)

at  Baxter

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 at Baxter:
Managing Canadian complaint evaluations, with expert product knowledge. This includes customer complaint receipt, evaluation, investigation, customer response, and complaint closure.
Submitting local & foreign medical device problem reports (MDPRs) to local Regulatory Authorities in accordance with the applicable regulations and answer any subsequent questions in collaboration with key stakeholders.

What you will be doing

• Providing information to Baxter business units for decision-making purposes.
• Triage incoming complaints from internal or external customers to determine next steps in the process based on level of risk.
• Provides oversight for all assigned complaints and related activities per defined procedures
• Timely and accurate processing of high risk and serious injury/death complaints
• Timely processing of customer due diligence activities, including French speaking customers
• Collect necessary complaint information per requirements
• Determine reportability of device complaints and submit associated Medical Device Problem Reports (MDPR’s) to Health Canada per regulations. Answer any subsequent questions received in collaboration with key stakeholders (i.e.
• Regulatory Affairs, Corporate Product Surveillance, Manufacturing).
• Liaise with Pharmacovigilance on combination drug/device adverse events.
• Evaluate complaint for need to investigate and coordinate sample retrieval.
• Liaise with Corporate Product Surveillance function(s), global Baxter manufacturing facilities, and 3rd party vendors to investigate complaints.
• Participate In defining investigation plan, including defining members of Investigation team and their roles and responsibilities, provides follow-up communication (written or verbal) of Investigation results with internal and external customers, as applicable
• Timely closure of complaints, as per procedure.
• Manage workflow; Identify and escalate issues.

EDUCATION LEVELREQUIRED:

• Bachelor of Science or Diploma with relevant quality work experience or equivalent

TYPE OF EXPERIENCE

• Working knowledge of GMPs, GDPs, Health Canada Regulations, ISO Standards and/or Manufacturing / Quality Assurance Experience

YEARS OF EXPERIENCEREQUIRED:

• 1 years relevant work experience in a GMP related industry or equivalent work experience

ADDITIONAL SKILLS / SPECIAL TRAINING / TECHNICAL SKILLS REQUIREDREQUIRED:

• Ability to prioritize multiple tasks.
• Excellent written/oral communication and organizational skills.
• Ability to develop and grow relationships with customers.
• Ability to work autonomously.
• Strong problem solving and analytical skills.
• Knowledge and application of computer systems for word processing, reporting, data analysis and complaint management.

• Providing information to Baxter business units for decision-making purposes.
• Triage incoming complaints from internal or external customers to determine next steps in the process based on level of risk.
• Provides oversight for all assigned complaints and related activities per defined procedures
• Timely and accurate processing of high risk and serious injury/death complaints
• Timely processing of customer due diligence activities, including French speaking customers
• Collect necessary complaint information per requirements
• Determine reportability of device complaints and submit associated Medical Device Problem Reports (MDPR’s) to Health Canada per regulations. Answer any subsequent questions received in collaboration with key stakeholders (i.e.
• Regulatory Affairs, Corporate Product Surveillance, Manufacturing).
• Liaise with Pharmacovigilance on combination drug/device adverse events.
• Evaluate complaint for need to investigate and coordinate sample retrieval.
• Liaise with Corporate Product Surveillance function(s), global Baxter manufacturing facilities, and 3rd party vendors to investigate complaints.
• Participate In defining investigation plan, including defining members of Investigation team and their roles and responsibilities, provides follow-up communication (written or verbal) of Investigation results with internal and external customers, as applicable
• Timely closure of complaints, as per procedure.
• Manage workflow; Identify and escalate issues