Quality System Engineer

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

· At least 2 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

Salary : $60,000