Quality Specialist

3 weeks ago

Mississauga, Canada BAXTER Full time

**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**:
**What You'll be doing**:

- 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. Provides consultative support on product related issues to the Business Unit and Sales and Marketing teams.
- Provides readily available product and technical information and support to Canadian customers.
- May be Involved in and/or lead customer site visits as assigned by management. Participate in continuous improvement activities and projects.
- May lead projects as assigned by management.
- Assists the Quality Manager - Product Surveillance in developing and maintaining the local Product Surveillance Standard Operating Procedures [SOPs].
- Conducts training on complaint management for all new hire(s) and existing employees as required.
- Any other duties as assigned by the Quality Manager-Product Surveillance

**What You'll Bring**:

- Bachelor of Science or Diploma with relevant quality work experience or equivalent
- Fluent in both English and French
- Working knowledge of GMPs, GDPs, Health Canada Regulations, ISO Standards and/or Manufacturing/Quality Assurance Experience
- Minimum 3 years relevant work experience in a GMP related industry or equivalent work experience
- Strong understanding of Health Canada GMP and Medical Device Regulations
- Ability to prioritize multiple tasks
- Excellent written/oral communication and organizational skills
- Ability to work autonomously
- Strong problem solving and analytical skills

LI-BAXGEN

**Reasonable Accommodations**

**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.

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