Quality Engineer

About the Role

The Quality Engineer supports Comecer Project Managers in managing orders from a quality perspective throughout the project lifecycle, including design reviews, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and aspects of Performance Qualification (PQ) related to VPHP cycle development.

The position services markets including Radiopharma, Pharma, and Cell & Gene Therapy (ATMP) projects in North America, covering equipment such as:

• Radiopharma: shielded hot cells, automation, synthesis and dispensing modules, LAF shielded isolators, sterility testing isolators, VPHP generators, solid target processing systems, dose calibrators, glove testers, and VPHP sterilization modules
• Pharma: aseptic handling and filling of liquid and powder APIs, dispensing custom R&D isolators, potent API processing isolators (PAPI), modular sterility testing isolators (MSTI), ATEX isolators, Baby Phill small batch vial filling, Combo Phill aseptic filling lines, fully automated combination product filling systems, Speedy Glove, DeconBox™
• Cell & Gene Therapy (ATMP): modular cell culture isolator (MCCI), FlexyCult™ incubation system

Responsibilities

• Support colleagues in drafting and finalizing technical documents and interpreting legal, regulatory, and project requirements
• Manage quality aspects of orders, including specific validation (DQ), validation documentation, and process controls
• Work with technical teams and third parties at customer sites to perform and complete SAT, IQ, OQ, VPHP cycle development, and VPHP PQ activities
• Develop and maintain quality procedures and controls at Comecer Inc. facilities to meet customer and regulatory requirements
• Collaborate with Comecer quality personnel and third parties to establish regulatory approval for Comecer disposable kits in North America
• Develop inspection methods to analyze product quality
• Implement systems to ensure conformity and accuracy in the production process
• Ensure product compliance with company and international quality standards
• Verify product alignment with technical specifications and take corrective action for non-conformities
• Plan and document control activities and inspections
• Perform other duties as required

Requirements

• Bachelor’s degree in a technical field or equivalent experience
• Quality Engineering experience in a manufacturing environment preferred
• Experience with ISO 9001 standards preferred
• Strong communication skills, both verbal and written, for interacting with all organizational levels
• Strong problem-solving ability
• Proficient in Microsoft Office suite
• Hands-on approach with the ability to meet deadlines

Working Conditions

• May require standing, walking, pushing, pulling, reaching overhead, and bending to the floor
• Occasionally exert up to 50 pounds of force; frequently exert up to 10 pounds of force
• Visual acuity required for reading instructions and computer screens
• Hearing ability required for understanding verbal instructions
• Normal office environment with occasional exposure to high noise levels and physical hazards on the manufacturing floor
• Capable of wearing appropriate PPE for extended periods