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medmix · 1 month ago

Healthcare Quality Systems Engineer

Flowery Branch, GA, USA

Full-time

Onsite

New Grad, Entry Level

$96K/yr - $106K/yr

medmix is a global leader in high-precision delivery devices, dedicated to innovation and technological advancement. The Healthcare Quality Systems Engineer will assist in implementing and managing the quality management system to ensure compliance with regulatory requirements and industry best practices, while also supporting continuous improvement efforts within the quality system.

Health CareManufacturingMedicalMedical Device

Responsibilities

Assist with the process of monitoring the quality system including records and results from processes and procedures to ensure product Quality and compliance

Support improvement efforts within the Quality system

Assist with setting the standard for QA documentation review regarding quality review thoroughness and timeliness

Ensure manufacturing and quality documentation is accurate, maintained, and reflects GMP, procedural and regulatory requirements. Provide constructive feedback to QA and Operations staff regarding documentation quality

Maintain knowledge of current regulatory requirements pertaining to medical device manufacturing and communicates requirements to other associate staff

Conduct weekly walk-throughs to ensure quality compliance and internal audits to comply with the current ISO standards

Ensure compliance to legal and company requirements with OSHA and other health and safety regulations, as well as continuous improvement of compliance regulations

Lead investigations of quality issues as required. Provide analysis and trend information to support these activities

Responsible for administration of and compliance with the ISO quality system and for administration as required to maintain and renew the certification upon expiration; for coordinating revisions to or required upgrades for the quality system; and for maintaining required Quality Manual, all quality records, process maps and work instructions for the location in Oakwood, GA

Maintain quality records procedure and coordinate non-conformance reporting

Review and approve non-conformance reports, calculate related cost of quality, coordinate cross-department issues and notify management team of trends or significant issues

Assist with writing and revising quality manual, regulations, policies, and related work instructions

Compile, analyze, and interpret statistical data related to quality operations

Responsible for monitoring outside vendors to insure they are following medmix quality processes