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Quality Specialist

Roanoke, VA 24018

Posted: 01/24/2023 Employment Type: Permanent Industry: Skilled Trades Job Number: DH476703124 Pay Rate: 41600

Job Description


Quality Speciality

Direct hire Excellent benefits

Day shift

$41k to start based on experience plus quarterly bonus

The Quality Specialist will work directly with the Production of Medical Devices and Engineering teams to ensure products conform to quality standards and establish compliance with the quality system.

Education

· Two (2) year Applied Science Degree and/or equivalent work experience required.

Experience

· Experience working in the medical device or other regulated industry.

· Working knowledge of ISO 13485 and FDA 21 CFR Part 820 requirements

· Experience with Process Validations

· Experience with internal and/or external audits

· Hands on experience with electronics

Strong Understanding

· Risk Management practices, including FMEA.

· Statistical techniques (statistics, process control, and process capability)

· Root Cause Analysis techniques

Responsibilities

· Coordinates CAPA investigations and implements corrective/preventive actions.

· Supports manufacturing by resolving manufacturing and supplier issues.

· Conducts non-conformance risk assessments.

· Ensures product conformity to internal and external quality requirements.

· Documentation, root cause analysis investigation, record management

· Supports internal, external, and supplier audits as needed.

· Strong analytical and problem-solving skills

INDSTO

Meet Your Recruiter

Dawn Harp

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