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Quality Specialist II
2 months ago
Quality Specialist role involves working with customers and suppliers to address quality issues, executing core quality functions, and participating in audits and continuous improvement projects.
Job Description
At Thermo Fisher Scientific, you'll work with a team dedicated to delivering high-quality products and services. As a Quality Specialist, you'll be responsible for ensuring the quality of our products and processes, working closely with customers and suppliers to resolve quality-related issues.
Responsibilities
- Process complaints, quarantines, change notifications, customer surveys, quality certificates, and internal audits.
- Administer recalls, customer advisories, field actions, and compliance reporting to regulatory bodies.
- Collect and analyze quality data, generating reports and metrics.
- Author Standard Operating Procedures, Work Instructions, and Flow charts.
- Support Quality Issue Reviews and CAPA investigations.
- Participate in internal and external audits of the Quality Management System.
- Contribute to continuous improvement projects through process improvement and task assignments.
Requirements
- Minimum Bachelor's Degree in a scientific field (chemistry, biology, biotechnology, or mathematics).
- Minimum three (3) years of applied experience in an ISO 9001, ISO 13485, and/or regulated environment.
- Two (2) years quality auditor experience preferred.
- Experience with post-market surveillance activities, CAPA, skilled investigation, root cause analysis, and containment.
- Experience crafting and driving presentations, interacting with customers, suppliers, and senior management.
- Experience using Quality Management Software (e.g., Master Control, Smartsheet).
Skills and Abilities
- Knowledge of Health Canada/FDA regulations preferred.
- Excellent oral and written communication skills.
- Excellent interpersonal skills.
- Strong computer and data analytical skills, using Microsoft office tools.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers an innovative, forward-thinking organization with outstanding career and development prospects.
