Company: Kelly Services
Posted on: September 22, 2022
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.
Essential Functions: 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. #TJP2022_SPEC
Keywords: Kelly Services, Chantilly , Quality Engineer, Engineering , Chantilly, Virginia
Didn't find what you're looking for? Search again!