QA Coordinator - Amico Clinical Solutions

Amico Corporation; Richmond Hill; On-site; CAD 60,000 - 80,000; Full time

Job summary

A leading company in healthcare solutions is seeking a QA Coordinator to support the Quality Management System. The role involves conducting audits, collaborating with teams, managing documentation, and ensuring compliance with industry standards. Candidates should possess a science degree and relevant experience in quality assurance. Strong problem-solving and communication skills are essential, along with a keen attention to detail. An opportunity to advance in quality management in a dynamic environment.

Qualifications

• 3+ years as Quality Assurance Coordinator or Supervisor.
• Certification in internal auditing would be an asset.
• Experience with Health Canada, ISO 13485, FDA and EU MDR requirements.

Responsibilities

• Ensure all processes comply with quality management systems.
• Assist in maintaining/updating the Quality Management System.
• Conduct regular inspections and audits to ensure compliance.

Skills

Communication

Interpersonal Skills

Problem-solving

Analytical Skills

Attention to Detail

Time Management

Multi-tasking

Education

Bachelor’s degree in a science related field

Job description

Job Description:

Position Summary:
The QA Coordinator provides assistance in ensuring that all process and procedures are implemented effectively and complying with Amico’s Quality Management System. This will include conducting internal audits, collaborating with teams and resolving issues, managing documentation and record keeping.
Education and Experience:

• 3+ years as Quality Assurance Coordinator or Supervisor
• Bachelor’s degree in a science related field
• Certification in internal auditing would be an asset

Required Skills and Competencies:

• Experience with Health Canada, ISO 13485, FDA and EU MDR requirements.
• Excellent written and verbal communication skills.
• Excellent interpersonal skills.
• Excellent problem-solving, analytical and decision-making skills.
• Excellent attention to detail.
• Excellent organizational, time management and multi-tasking skills.

Job-specific Duties and Responsibilities:

• Ensure all processes and procedures are compliant with Amico’s Quality Management System.
• Assist in maintaining/updating the Quality Management System.
• Ensure all non-conforming processes are captured and assessed using a risk-based approach and generate corrective and preventative actions.
• Record product NCR’s and investigate quality issues or product failures to determine root causes and agree corrective actions with relevant functions.
• Effectively implement the quality complaints handling system and drive improvements through trending of data and facilitating meaningful root cause analysis and timely closures of CAPAs.
• Conduct regular inspections and audits to ensure full compliance with quality standards.
• Actively participate in regulatory/accreditation audits.
• Working with cross-functional teams to address quality issues and improve processes.
• Actively support and implement the continuous improvement opportunities.
• Generate KPI weekly quality reports for ACS and AMO.
• Ensure adherence to current processes and procedures as well as health and safety guidelines.
• Provide training and assistance to all staff regarding process, procedures and QMS requirements.
• Other duties as assigned by the Global Quality & Regulatory Manager.