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Quality Specialist (P1 East) - Hoover, AL at BIOHORIZONS IMPLANT SYSTEMS

Hoover, Alabama, United States -

Full Time

Start Date

Immediate

Expiry Date

09 Mar, 26

Salary

0.0

Posted On

09 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Blueprint Reading, Precision Measuring Instruments, ISO13485, 21 CFR Part 820, 21 CFR Part 11, Communication Skills, Detail-Oriented, Problem-Solving, Analytical Skills, Independent Judgment, Computer Literacy, Adaptability, Recordkeeping, Calibration, Training Support, Manufacturing Validation

Industry

Medical Device

Description

The Quality Specialist can heavily influence the company’s compliance with quality system regulations and standards for product inspection, quality documentation controls, and quality system integrity. The success of the company overall based on their ability to coordinate internal and receiving inspections. The company’s compliance with Quality System Regulations and standards governing document changes and historical records. The perception of suppliers and regulators about the competence levels of P1 in meeting requests for information and in complying with applicable regulations. ESSENTIAL DUTIES AND RESPONSIBILITIES * Perform tasks associated with the implementation and maintenance of the company’s Quality Management System * Inspect device components and finished devices per established inspection procedures * Review and maintain completed device history records * Support the nonconforming materials system, including material review board (MRB) efforts * Support production activities and the transfer of product out of Quality, ensuring that necessary documentation is generated and maintained * Perform and maintain instrument and gage calibrations to ensure all daily production requirements are met * Maintain organized recordkeeping of the overall calibration system * Assist with validation activities to support manufacturing needs as required * Support training activities as required * Minimal travel (

Responsibilities

The Quality Specialist is responsible for implementing and maintaining the company's Quality Management System, conducting inspections, and supporting production activities. They also manage documentation and assist with validation activities as needed.