Quality Assurance Manager

2 weeks ago

Ottawa, Canada Thermo Fisher Scientific Full time

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

**How will you make an impact?**

**What will you do?**

A day in the Life:

- Measure and drive enhancements of Core QA processes (CAPA, Complaints, Quarantine, Recall, Internal Audit etc.)
- Manages Quality Systems including ISO 9001, ISO 13485, and ISO 17025.
- Ensures Quality Systems comply with the appropriate ISO Standards.
- Ensures timely periodic reviews and updates to the document management system.
- Coordinates with Global Quality and Regulatory colleagues and adopts best practices.
- Leads harmonization of processes globally where possible.
- Supports all functional departments within Canada to ensure integrity of the Quality Systems and compliance to all applicable regulations.
- Coordinates with Portfolio Management for new and existing products to resolve supplier issues including product complaints.
- Liaises with Legal as needed to address compliance matters.
- Develops, updates and supports internal quality audits of ail Canadian sites.
- Coordinates all product recalls.
- Develops and maintains written procedures, work instructions and/or manuals for each area of responsibility.
- Responds in a timely manner to all correspondence from business partners and global quality and regulatory.

**How will you get here?**

**Education**
- Bachelor of Science Degree in Chemistry, Bio-Chemistry, Biology, Engineering, or Applied Sciences.

**Experience**
- A minimum of 8 years of related experience in a responsible position in representative fields such as medical device manufacturing, healthcare, pharmaceutical, chemicals, educational or hospital environments.

**Knowledge, Skills, Abilities**
- Knowledge of ISO Certification requirements including ISO 9001 and ISO 13485. (ISO 17025 is an asset).
- Good supplier management, CAPA, complaint handling, supply chain knowledge.
- Knowledge of Health Canada regulations.
- Excellent oral and written communication skills.
- Effective and persuasive communicator with the ability to effectively convey ideas to all levels of management.
- Good organizational skills.
- Proficient at authoring procedures.
- Experienced lead auditor.
- Skilled problem solver using Practical Process Improvement (PPI) Business System or equivalent who works with a sense of urgency and is results oriented.
- Manufacturing, Distribution, and Supply Chain experience a plus.
- Strong computer and technical skills, including: data analysis and reporting using, Microsoft Excel, Access, Word, PowerPoint and Minitab.
- Ability to travel and work in a distribution environment; approximately 15% of the time.

**Benefits**

We offer competitive remuneration, annual 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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