Quality Assurance Scientist

Our clients contribution to healthcare is offering a range of diagnostic solutions clinical data management tools and process management expertise. Their goal is to provide solutions improving healthcare around the globe.

They are part of a team of life science companies who are developing products that are paving the way in the fight to save lives.

If you are looking for an opportunity to contribute your skills and knowledge our client is looking for a Quality Assurance Scientist.

In this position as the Complaint Handling Quality Assurance Scientist 1 you will be working within the Global complaint team providing a critical contribution to the overall quality and regulatory compliance of customer complaint investigations.

• Review evaluate and record activities and findings as part of an ongoing global quality process.

• Enter and submit complaints on behalf of fieldbased personnel
• Ensure supporting documentation is attached to complaints
• Ensure complaints are correctly classified and assign investigators/reviewers
• Design and Perform complaint investigations into the Chemistry/Immunoassay product line
• Conduct reviews of complaint trending to determine CAPA eligibility
• Escalation of product issues to management
• Complete the following documents as required Risk assessments Stop ship assessments CAPA requests
• Represent QA on development current business or product improvement projects

Skills to be successful in this role

• Exercises judgment within defined procedures and practices to determine appropriate action.
• Ability to maintain direct communication and collaboration with other functions such as Field Service Call center manufacturing R&D and other Post Market Surveillance teams
• Ability to follow up effectively will be necessary.
• Ability to identify and countermeasure common failure issues
• Robust documentation and strict adherence to approved procedures are a requirement in the highly regulated work environment
• Gain and utilize basic product technical awareness to facilitate informed evaluation of customer complaints records being reviewed
• Complete all needed records in a timely and accurate manner within Smart Solve (compliant management system (CMS)

Schedule: FT 40 hrs MF 8am 5 pm

Location: 100% remote or clients location in Miami FL

Benefits: Health Insurance Available Medical / Dental/ Vision

Qualifications

• Degree level in a Science or Engineering related discipline
• Min 2 yrs previous experience working in a laboratory environment or Quality role w/ previous experience in a CHU environment
• Good knowledge of FDA QSR and IS013485 requirements
• Ability to troubleshoot prioritize data analyze and problem solve

• Must be authorized to work in the US for any employer
• The position is subject to passing a background check and drug screen

Keywords: scientist quality assurance QA quality systems design control DHF quality control medical device quality production FDA ISO regulated environment manufacturing immunoassay US and international regulations Agile development engineering life science

By applying to this position you are confirming that you understand the requirements needed for this position and further confirm that you possess the necessary skills and requirements as outlined above.