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. 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.