Quality Specialist II

Job Description

The specialist will be responsible for managing Quality Assurance processes for customers to whom we distribute laboratory products and consumables, including Medical Devices & In-Vitro Diagnostic Products.

The Quality Assurance Specialist will establish best working practices with all functional teams, colleagues and collaborators within RSD and Thermo Fisher Scientific businesses ensuring that all processes are fully operational and effective within our European QMS.

Key Responsibilities:

Lead the QA critical complaints process, from acknowledgement to investigation and completion with timely updates for both supplier and customer.

• Maintain the Complaints tracker and create a live supplier contact database.

• Work proactively to reduce the number of complaints open over 30 days.

Manage and maintain the Change Notifications and Product Recalls received, work with customers and suppliers to ensure we are aware of any changes and issues with any products.

Support the SureTRACE program, initiate sureTRACE changes and discontinuations. Support any developments within the process and complete all necessary training.

Contribute to the creation and improvement of SOPs, WIs and policies as applicable and help to develop European QA documentation for our ISO 9001 Quality Management System.

Establish regular communication with other departments, to understand requirements and lead expectations.

Work closely with Thermo Fisher Scientific team in the Global QA team to understand their internal processes, and work towards establishing common processes.

Apply PPI methodology, establish QA processes and workflows that are fully auditable and included in the RSD ISO 9001 Quality Management System.

Provide robust QA support and training to business partners. 

Effectively perform your duties whilst acting all times in accordance with the Dignity at Work Policy, Code of Business Conduct and Ethics; and our values of Integrity, Intensity, Innovation and Involvement.

Embrace & Participate in Practical Process Improvement (PPI) initiatives to identify improvements and cost savings to the RSD/CCG businesses

Minimum Requirements/Qualifications:

• Science degree preferred

• Customer Services or Quality Assurance experience preferred

• High level of computer literacy

• General eye for business and good problem-solving skills

• Maintain a broad understanding of the product range

• Maintain a thorough understanding of local processes and procedures necessary to complete the role

• Ability to manage multiple priorities

• Strong organizational and time-management skills

• Excellent problem-solving skills

• Ability to effectively communicate both orally and in writing with key collaborator departments, suppliers and customers

Non-Negotiable Hiring Criteria:

• Able to communicate fluently in spoken and written English

• Database experience (MS Excel)

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.