Quality Assurance Specialist

Sonele Inc.; Markham; On-site; CAD 60,000 - 80,000; Full time

Job summary

A quality assurance company in York Region, Markham is seeking a dedicated QA Specialist to manage quality processes and coordinate investigations with suppliers. Candidates should possess strong analytical skills and at least two years of experience in ISO or FDA compliant environments. The role requires attention to detail and excellent communication skills. The ideal candidate will be involved in continuous improvement methodologies and will work in various settings, ensuring compliance with quality standards.

Qualifications

• Experience in a continuous improvement methodology and related analytical tools.
• Experienced internal or external auditor; lead auditor experience preferred.
• Ability to travel and work in a laboratory, warehouse, or manufacturing environment.

Responsibilities

• Coordinate investigations with suppliers and communicate root cause to customers.
• Collect and analyze quality data, and prepare and distribute quality reports.
• Facilitate the quarantine and recovery of products.

Skills

Organized and works with a sense of urgency

Attention to detail

Ability to multi-task

Customer focused

Flexible team player

Excellent oral and written communication skills

Skilled problem solver with a results orientation

Strong computer and analytical skills

Education

Bachelor's Degree or equivalent experience in a technical/scientific field

Minimum two years' experience in ISO and/or FDA cGMP environment

Tools

Microsoft Excel

Microsoft Access

Microsoft Word

Microsoft PowerPoint

Minitab

Data Warehouse tools

Job description

Job Description

Key Responsibilities

• Participate in all aspects of the QA job function, e.g. processing of Complaints, Quarantine, Recovery, Customer Recovery and Advisories (QRRs), change notifications, customer surveys, quality certificates, internal audits, SalesLogix tickets, generation of supplier and team metrics, etc.
• Process the download and distribution of Complaints daily. Identify those Complaints requiring escalation.
• Work with customer service to fully document the customer's allegation and facilitate the return of product to be evaluated.
• Coordinate investigations with suppliers, and communicate root cause and corrective actions to customers. Coordinate investigation of quality issues with customers and suppliers.
• Review, approve and communicate root cause and corrective action to stakeholders.
• Facilitate the quarantine, recovery and disposition of products including those that may be sensitive in nature for regulatory or legal reasons.
• Collect and analyze quality data, run Oracle queries, and prepare and distribute quality reports.
• Respond to customer surveys and Requests for Proposal, (RFPs) in a timely manner.
• Create and revise QA procedures and work instructions. Participate in internal audits of the Quality Management System. Participate in continuous improvement of core processes, using Practical Process Improvement (PPI). Present QA functions and provide training as required to departments outside of QA.
• Execute projects and complete other duties as assigned.

Minimum Requirements/Qualifications

• Organized and works with a sense of urgency.
• Attention to detail.
• Ability to multi-task.
• Customer focused.
• Flexible team player.
• Excellent oral and written communication skills.
• Experienced in dealing with customers and suppliers. Skilled problem solver with a results orientation. Strong computer and analytical skills, including: data analysis and reporting using, Microsoft Excel, Access, Word, PowerPoint, and Data Warehouse tools.
• Experienced in a continuous improvement methodology and related analytical tools, e.g. Six Sigma, PPI, Lean, Minitab, Corrective and Preventive Action (CAPA), run charts, flow charting, Pareto charts, pivot tables etc.
• Minimum two years' experience working in an ISO (13485 preferred) and/or FDA current Good Manufacturing Practices (cGMP) environment. Experienced internal or external auditor, lead auditor experience preferred.
• Experience working with a quality information management system, Master Control preferred. Bachelor's Degree or equivalent experience in a technical/scientific field, e.g. engineering, chemistry, biology, or mathematics.
• Ability to travel and work in a laboratory, warehouse or manufacturing environment; less than 15% of the time.

The above information on this job description and specification has been designed to indicate the general nature and level of work performed by employees within this job. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.