Salary: *THIS IS AN ON-SITE, 5 DAYS A WEEK POSITION IN CONSHOHOCKEN, PA*

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 Bachelors 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