Overview
Project Training & Quality Manager Jobs in Myrtle Point, OR at Inizio Engage
Purpose
The Quality System Engineer is responsible for verifying operational compliance with the quality system and ensuring all products and services meet established quality standards.
Responsibilities
Initiate and lead investigations for Quality Events (Deviations, Non-conformances, CAPAs, Customer Complaints, SCARs, etc.)
Support coordination and execution of training/re-training and corrective/preventive actions associated with Quality Events
Support tracking and trending of Quality Events
Support and/or perform supplier qualifications
Support and/or perform internal and external audits
Support development and revision of procedures/controlled documents according to FDA, AATB, and other applicable regulations
Support review of equipment, process, and software qualification, verification, and/or validation plans, execution data, and summary reports
Review quality control records to include equipment cleaning/maintenance, environmental monitoring, and supply inspections
Perform tracking and trending of Environmental Monitoring Results in accordance with standard operating procedures
Support authoring/revision of standard operating procedures in accordance with relevant regulations/standards, and internal organizational policies and standard operating procedures
Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB Standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures
Maintain acceptable attendance and punctuality for scheduled work hours and meetings
Ensure completion of assigned tasks and responsibilities within defined timeframes
Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary
Perform other duties as assigned
Skills
Ability to work independently and in a team environment
Excellent attention to detail and organization
Excellent written and verbal communication
Highest level of ethics and integrity
Ability to lead and motivate the right behaviors
Ability to multi-task and work in a fast-paced environment
Strong technical writing
Effective project management
Proficiency in Microsoft Office
Qualifications/Requirements
Bachelor’s degree in biological science, engineering, or related field, from an accredited college or university required. Additional related work experience may be substituted on a year-for-year basis in lieu of the degree
At least 2-4 years of experience in an FDA regulated environment for HCT/Ps, medical devices, pharmaceuticals, and/or or related field required
At least 1 year of experience in conducting quality investigations and/or audits preferred
Clearance of favorable background investigation required
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Title: Project Training & Quality Manager
Company: Inizio Engage
Location: Myrtle Point, OR
