Quality Engineer

Job Description The  Quality Engineer  supports Comecer Project Managers in the management of the orders from a quality point of view throughout the project including design reviews, FAT, SAT, IQ, OQ and some aspects of PQ as they relate to VPHP cycle development.   The markets this position services include  Radiopharma, Pharma and Cell & Gene Therapy (ATMP) projects in North America; including, but are not limited to:   Radiopharma  – shielded hot cells and 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™   Additional Information ESSENTIAL JOB DUTIES:  Quality  Support colleagues in drafting and finalizing technical documents and the interpretation and application of legal, regulatory and project requirements  Quality management of orders in relation to:  Specific validation (DQ)  Validation documentation  Process controls  Work with technical team in the field as well as 3rd parties at customer sites to perform and successfully complete SAT, IQ, OQ, VPHP Cycle development and VPHP PQ activities.  Work with other colleagues to develop and maintain quality procedures and controls at Comecer Inc. facilities in North America to conform to customer and regulatory requirements.  Work with Comecer quality personnel and 3rd parties to establish regulatory approval for Comecer disposable kits for sale in North America  Develop inspection methods to analyze product quality  Implement a working system to ensure conformity and accuracy in the production process  Ensure products compliance with company and international quality standards  Ensure that the product corresponds to the desired technical specifications and take corrective action to resolve non-conformities  Plan and document control activities and inspections  Other duties as required. Qualifications QUALIFICATIONS:  Bachelor’s degree in technical field or equivalent experience.   Quality Engineering experience in a manufacturing environment preferred.   Experience with International Standardization Organization (ISO) standards 9001preferred.  Ability to communicate efficiently and effectively with people at all levels of the organization, both verbally and in written form.   Strong problem-solving ability.  …