Senior/Staff Quality Assurance Engineer

At Thermo Fisher Scientific team, youll 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.

The role is based in Johannesburg, South Africa

The main purpose of the role is leading the site Quality Program and maintaining the Quality Management System (QMS).

A day in the Life:

• Provide quality system leadership to assure internal policies, customer expectations and regulatory requirements are met.
• Manage the site QMS as management representative, including assuring effective management reviews, complaint handling, CAPA system, change control and internal auditing.
• Perform statistical analysis and work with operations partners to investigate trends, conduct root cause analysis, and lead corrective actions.
• Drive a culture of continuous improvement.
• Perform training to site personnel on Quality procedures.
• Lead the implementation and maintenance of an ISO 13485 certified QMS.
• Stay aware of country specific regulatory requirements for required registrations.
• Work with Regulatory to acquire required product and site registrations.
• Other duties as assigned by direct Manager.

Keys to Success:

Education

• B.S. degree in Engineering, Biological Sciences, or related field preferred.

Experience

• Proven experience in Quality environment required.
• Knowledge in ISO 13485 standards.

Knowledge, Skills, Abilities

• Possess strong organizational skills with the ability to lead and prioritize multiple tasks.
• Ability to communicate effectively with multiple levels of staff throughout the organization.
• Self-motivated, can work as a teammate and/or independently.
• Customer focused.

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.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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