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Quality Assurance Scientist
$73k-89k (estimate)
Full Time 1 Month Ago
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Sunrise Systems is Hiring a Quality Assurance Scientist Near Miami, FL

Position title: Quality Assurance Scientist
Duration: 6 months
Client location: Miami, FL
100% Remote role Description
  • The Complaint Quality Assurance Scientist I (CHU) position within the Global complaint handling team provides a critical contribution to the overall quality and regulatory compliance of customer complaint investigation. More specifically they will review, evaluate, and record activities and findings as part of an ongoing global quality process.
This position will follow established procedures to
  • Enter and submit complaints on behalf of field-based 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.
  • Exercises judgment within defined procedures and practices to determine appropriate action.
  • Direct communication and collaboration with other functions such as Field Service, Call center, manufacturing, R&D, and other Post Market Surveillance teams will be fundamental to the success of this role.
  • Ability to follow up effectively will be necessary.
  • Data analysis and problem-solving skills are necessary 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)).
  • Complete all needed records in a timely and accurate manner.
Knowledge/Educational Requirements:
  • Degree level in a Science or Engineering related discipline
  • 2 years' experience in a laboratory environment or Quality role with previous experience in a
  • CHU environment
  • Good knowledge of FDA QSR and IS013485 requirements
  • Good Troubleshooting skills

Job Summary

JOB TYPE

Full Time

SALARY

$73k-89k (estimate)

POST DATE

05/20/2024

EXPIRATION DATE

05/31/2024

WEBSITE

sunrisesystems.com

HEADQUARTERS

PEMBROKE, MA

SIZE

50 - 100

TYPE

Private

CEO

HENRY C APPLETON

REVENUE

$5M - $10M

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The job skills required for Quality Assurance Scientist include Quality Assurance, Problem Solving, Chemistry, Collaboration, Troubleshooting, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Assurance Scientist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Assurance Scientist. Select any job title you are interested in and start to search job requirements.

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The following is the career advancement route for Quality Assurance Scientist positions, which can be used as a reference in future career path planning. As a Quality Assurance Scientist, it can be promoted into senior positions as a Quality Assurance Specialist II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Assurance Scientist. You can explore the career advancement for a Quality Assurance Scientist below and select your interested title to get hiring information.