Position Summary:
We are seeking a Quality Assurance Inspector to ensure compliant processing of Device History Records (DHRs) and perform the final release of products.
The candidate will be responsible for inspecting purchased incoming components, ensuring that they meet specifications.
Additionally, this role will include maintaining the calibration of measuring devices and supporting the Quality Team in maintaining, implementing, and improving Quality Systems in compliance with FDA 21 CFR Part 820 and Global Standard ISO 13485:
2016.Key Responsibilities:
Review Device History Records (DHRs):
Ensure DHRs and associated documentation comply with FDA requirements (820.80, 820.184) and Global Standard ISO 13485:
2016 §7.5.1 for final product release.
Component Inspection:
Inspect incoming components and review documentation to comply with FDA requirements (820.72, 820.90) and Global Standard ISO 13485:
2016 §7.4.3, ensuring that only acceptable parts are released.
Perform Incoming Inspections:
Inspect components to critical dimensions as per specifications and/or drawings, ensuring accuracy and compliance.
Utilize Measurement Instruments:
Properly understand and use measurement instruments and ensure their calibration and verification are maintained per required specifications.
Document Management:
Ensure accurate and complete records are maintained, in line with FDA and ISO standards.
Nonconformance Tracking:
Identify and track nonconformities found during inspections and work with the Quality Team to resolve issues.
Calibration Coordination:
Coordinate calibration schedules with equipment owners to ensure timely calibration of production tools and equipment according to FDA 820.72 and ISO 13485:
2016 §7.6.
Training & Support:
Support the production team in understanding Device History Records and Good Documentation Practices.
Provide guidance and lead by example, teaching others in best practices.
Workplace Safety:
Maintain a clean, safe, and organized work environment, ensuring adherence to safety protocols.
Additional Duties:
Perform other related tasks as assigned by management.Qualifications:
High School Diploma (or GED).
Competent team-worker.
Great attention to detail.
Good communication skills.
Ability to read and write English fluently.
Willingness to accurately operate daily routine work as well as challenging individual cases.
Preferable experience in Medical Device industry.
Preferable experience in QA/QC function.
Preferable knowledge of FDA regulations and ISO standards.
GD&T fundamentals experience preferred
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