Quality System Engineer

Job Description

Job Description

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