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.

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

• Radiopharma: Shielded hot cells, automation, synthesis and dispensing modules for vials and syringes, LAF shielded isolators, sterility testing isolators, VPHP generators for sterilization, 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 line for RTU vials, syringes, cartridges, fully automated combination product end-to-end filling systems, Speedy Glove, DeconBox™.
• Cell & Gene Therapy (ATMP): Modular cell culture isolator (MCCI), incubation system for advanced therapy labs FlexyCult™.

Responsibilities

• Support colleagues in drafting and finalizing technical documents and interpreting and applying legal, regulatory, and project requirements.
• Manage quality aspects of orders, including specific validation (DQ), validation documentation, and process controls.
• Work with the technical team in the field 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 in North America to conform to 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 International Standardization Organization (ISO) standards 9001 preferred.
• Strong communication skills, both verbal and written, for interacting with all levels of the organization.
• Strong problem-solving ability.
• Proficient in Microsoft Office suite.
• Hands-on approach with the ability to meet deadlines.

Job Specifications

• Physical demands may include standing, walking, pushing, pulling, reaching overhead, and bending to the floor.
• Exert up to 50 pounds of force occasionally and/or up to 10 pounds of force frequently.
• Visual acuity required for reading written instructions and computer screens.
• Hearing ability required for understanding verbal instructions.
• Working conditions include a normal office environment with occasional exposure to high noise levels and/or physical hazards when visiting the manufacturing floor.
• Capable of wearing appropriate PPE for extended periods.