Complaint Handling Specialist

Job summary

The specialist will manage complaint processing, analysis, and quality-related investigations while ensuring compliance with regulatory standards. They will collaborate with cross-functional teams and communicate with healthcare providers to gather necessary data for nonconformance investigations.

Job details

Mississauga, Canada (Onsite – Hybrid) Complaint Management Specialist – 12 Month Contract Sonova is seeking a Complaint Management Specialist to support complaint handling, complaint analysis, and quality-related investigation activities. This role is responsible for processing complaints in a timely manner, supporting complaint investigations, gathering data for nonconformance investigations, and ensuring complaint files are reviewed and closed in accordance with established processes and applicable regulations. Responsibilities: • Record and evaluate complaint submissions • Support complaint investigations and prepare complaint risk assessments when required • Conduct complaint analysis and gather data to support investigations of nonconformances • Collaborate with cross-functional teams, including Customer Service, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing, and R&D • Communicate with health care providers, HCP staff, and/or patients to obtain relevant complaint information • Coordinate with other departments to provide complaint data reports as needed • Receive returned goods and send them to engineering for analysis when needed • Review and close complaint files while ensuring timely complaint processing More about you: • Bachelor’s degree in engineering, audiology, quality, regulatory, compliance, or a related discipline required • 0–3 years of experience in the medical device industry or quality • Knowledge of ISO 13485, EU MDR, QSR 21 CFR 820, MDSAP, or related quality/regulatory standards preferred • Strong problem-solving skills with a focus on root cause analysis and problem prevention • Understanding of DMAIC investigation tools and descriptive statistics preferred • Prior experience as a complaint specialist in the medical device industry is a plus • Strong organization, communication, presentation, and prioritization skills • Ability to work with cross-functional teams and manage multiple activities, projects, and priorities • Proficient user of MS Office, including Excel, Word, and PowerPoint • Experience with Quality Management System software, Minitab, and SAP R/3 or S/4 preferred Travel: 5% travel may be required Don't meet all the criteria? If you’re willing to go all in and learn, we'd love to hear from you! We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered. Sonova does not recruit via app, telegram, carrier pigeon or any other format that does not include speaking with an actual human. If you are offered a job without speaking with someone, please contact Sonova HR. What we offer: Exciting and challenging work environment Collaborative culture Opportunities for continuous self-improvement Opportunities for flexible hybrid model work environment A company that values diversity and inclusion Rich benefits plan including wellness benefit, paramedical (massage therapist, naturopath, etc.) and competitive compensation including variable component and employer match on pension contributions Mentorship program and career development plans This role's pay rate is: $48,000 - $60,000 CAD annually. This role is incentive eligible. Sonova Canada is now a certified Great Place to Work® May 2024- May 2025. How we work: At Sonova, we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team-customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.

What you’ll do

The specialist will manage complaint processing, analysis, and quality-related investigations while ensuring compliance with regulatory standards. They will collaborate with cross-functional teams and communicate with healthcare providers to gather necessary data for nonconformance investigations.

Requirements

Candidates must hold a bachelor's degree in engineering, audiology, quality, or a related discipline. 0-3 years of experience in the medical device industry and knowledge of quality standards like ISO 13485 are preferred.

Benefits

• Wellness benefit
• Paramedical services
• Competitive compensation
• Variable component
• Employer match on pension contributions
• Mentorship program
• Career development plans

Listed skills

• SAP · Preferred
• Problem solving · Preferred
• Organization · Preferred
• Quality assurance · Preferred
• Regulatory Compliance · Preferred
• Data analysis · Preferred
• MS-Office · Preferred
• Communication · Preferred
• Root Cause Analysis · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Complaint handling
• Quality assurance
• Regulatory compliance
• Root cause analysis
• Data analysis
• Medical device industry
• ISO 13485
• EU MDR
• QSR 21 CFR 820
• MDSAP
• Problem-solving
• Communication
• Organization
• MS Office
• SAP
• Minitab
• Data Reporting
• Regulatory Affairs
• Complaint Investigations
• Hybrid Model
• Medical Affairs
• Medical Devices
• Deviation Investigations
• Microsoft Excel
• Title 21 Of The Code Of Federal Regulations
• Quality Management Systems
• Computing Platforms
• Audiology
• Management
• Customer Service
• Regulatory Compliance
• Define Measure Analyze Improve And Control (DMAIC)
• Innovation
• ISO 13485 Standard
• Problem Solving
• Mentorship
• Microsoft Office
• Microsoft PowerPoint
• Presentations
• Quality Assurance
• Risk Analysis
• SAP R/3
• Time Management
• Medical Device Reporting
• Investigation
• Root Cause Analysis
• Prioritization

Job areas

• Healthcare
• Engineering
• Manufacturing
• Customer Service & Support
• Complaints Handler
• Quality Assurance Specialist
• Product Graders and Testers (except Foods and Beverages)
• Inspectors, Testers, Sorters, Samplers, and Weighers

More jobs from Sonova Group