• Quality Engineer

    Kelly Services Chantilly, VA 20151

    Job #2278952340

  • 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

    Why Kelly ® Engineering?

    Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.

    About Kelly ®

    At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

    Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.