Quality Specialist Ii
4 weeks ago
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
**Location/Division Specific Information**:
Onsite at Ottawa, ON
**Discover Impactful Work**:
The Quality Specialist will work directly with customers and suppliers to quickly address quality related issues. You will be responsible for the daily execution of core quality functions/ processes under the supervision of the Quality Assurance Manager
**What will you do**:
- Participate in all aspects of the QA job function, e.g. processing of complaints, quarantines, change notifications, customer surveys, quality certificates, internal audits, generation of supplier and team metrics, etc
- Support with Recalls, Customer advisories, Field actions and complete compliance reporting to regulatory bodies.
- Collect and analyze quality data and distribute quality reports.
- Author Standard Operating Procedures, Work Instructions, Flow charts and support Quality document review and other applicable departmental documents
- Support with Quality Issue Reviews or CAPA investigations performed by the functional staff to ensure that corrective action plans are detailed, complete and timely.
- Participate in both internal and external audits of the Quality Management System
- Participate in continuous improvement projects through practical process improvement and tasks as assigned by the Quality Manager.
**How will you get here?**
**Education**:
- Bachelor’s Degree or equivalent experience in a technical/scientific field, e.g. Chemistry, Biology, or Mathematics
**Experience**:
- 3+ years of applied experience in an ISO 9001, ISO 13485 and/or regulated environment.
- 3+ years quality auditor experience
- Experience with post market surveillance activities such as recalls, customer notification, field actions.
- Experience with CAPA, skilled investigation, root cause analysis and containment activities
- Experience in crafting and driving presentations.
- Experience interacting with customers, suppliers, and senior management.
- Experience using Quality Management Software, e.g Mater Control
**Knowledge, Skills, Abilities**:
- Knowledge of Health Canada regulations.
- Excellent oral and written communication skills
- Strong computer and data analytical skills, using Microsoft office tools.
**Physical Requirements / Work Environment**:
**May require 0-25% as needed travel to support audits.**:
**Benefits**:
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Accessibility/Disability Access**:
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