Quality Specialist Jobs

Within the Thermo Fisher Scientific Bio- Production Group, the Post Market Surveillance Coordinator will manage the Post Market Surveillance (PMS) process to ensure continuous compliance with domestic and international regulatory requirements. They will be responsible for monitoring the safety, quality, performance, and efficacy of the medical products in the market. Monitor, collect, and trend stability data on IVD and 510K/Drug Master File Products.

This individual will act as lead to run systemic gathering and analysis of data, resulting in substantiated conclusions and identifying preventive or corrective actions of regulated products. Find opportunities to improve the usability, performance, and safety of devices.

What will you do?

• Apply Risk Management File and Clinical Evaluation content to PMS processes.
• Completing field activity (notification, corrections, removals) as necessary.
• Act as a liaison between PMS and other QMS elements (Design Engineering, Risk Management, Clinical Affairs, Regulatory Affairs, Marketing and Engineering).
• Ensure appropriate documentation of key data, analysis, and decisions in complaints and supporting documents and records.
• Evaluate current regulations, standards, and guidance impacting PMS systems on an ongoing basis and implement solutions to ensure continued regulatory compliance.
• Supporting internal and external audits.
• Develop and deliver post market solutions to support new business / distribution channels / projects
• Perform general QA and PMS related duties on an as needed basis to support department objectives and business needs. This includes but is not limited to, generating quality data for analysis, management review or in support of other objectives.
• Identify individual opportunities for improvements and leading / participating in project level activities for continuous improvements.
• Responsible for monitoring, investigating, tracking, and reporting on the performance of Thermo branded products as well as other products manufactured for OEM customers.
• Support CAPA process activities for both product and process related issues.

How will you get here?

• Bachelor's degree in Life Sciences and/or Laboratory Science is preferred or an equivalent combination of education, experience and/or licensure/certification.
• The position requires a high degree of independent prioritization, review, and approval of work. Function with little to no supervision.
• Communicate effectively both verbally and written with internal and external customers/personnel in a professional manner. Strong writing and facilitation skills.
• The required skills, knowledge and abilities that are typically acquired through a minimum of 3+ years medical device experience in quality assurance or related field.
• Must have demonstrated hands on, results oriented, multi-tasking response to the urgent needs of the company and show a strong track record of meeting deadlines.
• Must have experience and knowledge of ISO 13485:2016, 21 CFR Part 820, IVD Directive 98/79 EC, IVDR 2017/746 including but not limited to MDSAP.
• Proficient in Microsoft Word and Excel. Experience in Master Control and/or SAP preferred

Physical Requirements:

• Position will require sitting and standing and employee may occasionally lift and/or move up to 10 pounds.
• Position may require frequent communication and walking to other areas in which designated PPE will be required.

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