- 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.
- 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.
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Quality Assurance Scientist - Miami, United States - Pyramid Consulting, Inc
Description
Immediate need for a talented Quality Assurance Scientist. This is a 06+ months Contract opportunity with long-term potential and is located in Miami, FL(Remote). Please review the job description below and contact me ASAP if you are interested.
Job ID:
Pay Range: $24.67/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
Key Requirements and Technology Experience:
Our client is a leading Healthcare Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
