Quality Engineer (Chantilly, VA)
Our client, a manufacturer of automated medical device technology, a pioneer in microplate technology, is currently hiring a Quality Engineer. Client is opened to a Direct Hire or Contract to Hire arrangement.
The Quality Engineer will be responsible for QA manufacturing, supplier management program, and calibration program. The QA Engineer will provide the necessary support and guidance to ensure that all applicable quality standards are met in accordance with regulatory requirements and company policies for all products and systems.
The Quality Engineer maintains FDA (Food & Drug Administration) and ISO (International Organization for Standardization) regulatory requirements. Key elements of focus are supplier evaluation and approval, calibration program and QA manufacturing support. Key responsibilities will include:
Conducting risk analysis related to the systems being supported.
Conducting Internal / External audits and generate audit reports.
Oversight of all non-conformities related to the manufacturing operations area.
Generating and review of trend data reports and metrics as required.
Oversight of Supplier Management Program, Calibration Program and Non-conforming MRB (Material Review Board).
Success Factors: Must be a Team Player, Ability to communicate effectively with all levels of technical and professional personnel. Excellent problem-solving skills. Adaptable to change and ability to multi-task. Must possess a hands-on approach that encourages improvement.
Minimum Qualifications / Education:
B.S. Degree in Engineering or any science related field preferred, 3 years related experience in regulated industry in lieu of degree will be considered.
Broad knowledge 21 CFR 820, ISO 13485, ISO 14971. The ideal candidate will also possess Quality Auditor qualification.
Client is a leading designer a leading designer and manufacturer of fully-automated ELISA and Chemiluminescence microplate immunoassay workstations, and other-associated consumables and accessories, manufacturing products all seamlessly integrated with advanced detection/ fully-automated sample and reagent handling.
Specialties include multiplexing, automation, ELISA, DS2, microplates, DSX, Agility, Multiplier, Clinical Laboratory, Autoimmune, Infectious Disease, Clinical diagnostics, and work form RUO/LDT labs.
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