QA Process Engineer

Hardy Diagnostics

4d•Onsite

About The Position

The QA Process Engineer supports compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements. This position is responsible for activities ranging from product development through commercialization. This is a hands-on role where the QA Process Engineer will apply diversified knowledge of engineering, quality principles and practices for medical devices and laboratory use only products.

Requirements

Bachelor’s degree (B.S./B.A.) in engineering or related discipline
Minimum three (3) years of experience working in a regulated industry
Minimum two (2) years of experience in quality in a regulated industry

Responsibilities

Maintains and improves the quality system in accordance with FDA Quality System Regulation and ISO 13485 requirements
Supports quality assurance activities, including, but not limited to: Risk Management, internal and external audits, NCMRs and CAPAs
Investigates product quality problems (NCs and deviations) and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause
Manages the Control of Non-conforming Products (CNP) in collaboration with the applicable stakeholders, to ensure timely reporting, analysis, and resolution of non-conforming material
Leads/supports the resolution of quality issues related to non-conformance reports, deviations, customer complaints and CAPAs
Oversee the deviation process for the review and approval of manufacturing deviations
Supports manufacturing team in the maintenance and continuous improvement of product and manufacturing processes
Leads and administrates the CNP and CRB meeting
Serves as subject matter expert for root cause analysis
Provides QE support to production, purchasing and engineering
Supports/leads test method validation activities and/or other validation activities as needed
Develops and initiates sampling procedures and statistical process control methods
Other duties/ activities may be necessary to support departmental or company goal