Quality Engineer

DESCRIPTION

The Quality Engineer is responsible for providing quality assurance knowledge and hands-on support for all aspects of new product launches and production operations and ensuring that all site operations remain compliant with all FDA regulations, ISO standards, customer requirements, and internal policies and procedures.

Under the direction of the site Quality Manager, with a dotted reporting line to the Operations Manager, the Quality Engineer will be the owner of: quality planning; validations; FMEA and risk analysis; first article inspections; capability studies; design of experiment (DOE); developing, reviewing, and/or revising procedures; variance and complaint investigation and resolution; root cause analysis; corrective and preventative actions; and all other areas of quality control programs in a cGMP and ISO 13485 environment.

The Quality Engineer will also be responsible for providing Quality representation and support in: the ongoing development, evaluation, and improvements of Viant’s quality programs and systems; quality assurance testing methodology; internal and external audits; vendor qualifications; training initiatives and programs; cross-functional process improvement activities; and any other business initiative requiring Quality support.

RESPONSIBILITIES

  • Follow and ensure that all personnel comply with FDA regulations, ISO standards, customer requirements, and SOPs as defined by Viant’s policies and procedures
  • Represent Quality in signing on Change Orders
  • Manage all Quality responsibilities for assigned manufacturing changes and new product launches, including but not limited to: developing and executing process validation protocols and publishing reports; develop area, process, and supplier quality plans and out-of-control-action plans; implement statistical process control (SPC) in manufacturing processes where applicable
  • Participate in manufacturing review and new product testing to ensure quality compliance and that all products meet or exceed customer requirements
  • Monitor (by performing machine and process capability and performance studies); recommend improvements (to processes, procedures, systems, and machinery, etc.) to increase quality compliance and/or to meet or improve productivity and specification standards; present improvement plans and obtain management approval; and implement approved improvements; provide any related reports and documentation required for implementation
  • Participate in installation qualifications (IQ), operational qualifications (OQ), and performance qualifications (PQ); draft and/or review protocols and reports; qualify/validate production processes
  • Ensure that all documentation is completed in a timely manner and follows established policies, practices, and procedures
  • Investigate customer complaints including root-cause analysis; develop and implement corrective action plans; document findings, and communicate with customers
  • Lead or support by providing Quality representation for internal and external audits and customer visits
  • Provide training on new or updated manufacturing processes or procedures
  • Train Quality and Manufacturing personnel on specifications, inspection and testing activities, new product audits, and environmental controls to ensure understanding and compliance; request training, training support, and/or re-training as needed
  • Track all non-conformance reports, material review board (MRB), and part issues
  • Ensure part and/or product compliance to specification by performing independent inspection of components and finished goods; provide feedback and implement improvements to inspection process and testing procedures to increase quality compliance
  • Provide quality support and representation for cross-functional initiatives and projects
  • Use lean manufacturing root cause analysis/problem solving methods to identify opportunities to increase safety and quality compliance and to reduce cost, lead time, inventory, and defects
  • Perform other duties as needed

REQUIREMENTS

  • 3+ years of work experience in a Quality Engineering role or equivalent experience
  • Experience in contract manufacturing and/or manufacturing environment preferred but not required
  • Experience working in a regulated environment (ISO 13485, 21 CFR 820, or other) preferred but not required
  • Experience in medical device manufacturing preferred but not required
  • Injection molding experience preferred but not required
  • Advanced computer capabilities including Microsoft Office software
  • Strong interpersonal, written, and oral communication skills
  • Well organized; able to multi-task, prioritize, and manage multiple deliverables while working in a fast-pace environment
  • Problem-solving skills and critical thinking
  • Highly motivated, focused, self-starter
  • Quality-driven customer service
  • Able to work individually and as part of a team
  • Knowledge and familiarity with optical gauging product (OGP), coordinate measuring machine (CMM), other mechanical measurement equipment (indicators, micrometers, etc.), and other measuring devices used to ensure quality and acceptability of product
  • Able to read and interpret blueprints
  • Familiar with geometric dimension & tolerance (GD&T) procedures and requirements
  • Knowledge of statistical techniques (design of experiments, measurement R&R, statistical process control) preferred but not required
  • Working knowledge of and experience with quality management software
  • Knowledge of FDAQSR, ISO 13485, and ISO 14971 Risk Assessment preferred but not required

EDUCATION

  • Bachelor’s degree in engineering or equivalent experience

PHYSICAL REQUIREMENTS

  • Some of the work is performed in a typical office environment and includes long periods of sitting at a desk, computer use, and frequent use of hands
  • This position does require moderate amounts of walking, standing, bending, kneeling, stooping, pushing, pulling, reaching, lifting, and twisting
  • Employee may be required to exert up to 50 pounds of force occasionally, and/or up to 20 pounds frequently, and/or up to 10 pounds of force constantly to move objects
  • Worker is required to have close visual acuity to perform activities such as:
    • Preparing and analyzing data and figures
    • Transcribing
    • Viewing a computer screen
    • Extensive reading
    • Visual inspection involving small defects, small parts, and/or machine operation
    • Using measurement devices
    • Assembly or fabrication of parts at distance close to the eyes
  • Some travel may be required

CONDITIONS

Some of the Quality Engineer’s responsibilities and duties are performed on the production floor and/or in the warehouse of a manufacturing plant that can be hot in summer, cold in winter, hazardous, noisy, and dusty. The worker may be subject to:

  • Inside environmental conditions: Protection from weather conditions but not necessarily from temperature change
  • Noise: Sufficient noise to cause a worker to shout in order to be heard above ambient noise
  • Vibration: Exposure to oscillating movements of the extremities or whole body
  • Hazards: A variety of physical conditions such as proximity to moving mechanical parts, moving vehicles, electrical current, working on scaffolding and high places, exposure to high heat or exposure to chemicals

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ABOUT VIANT

At Viant, we focus on providing end-to-end solutions for medical device OEMs. Our deep materials expertise—combined with our experience in engineering, manufacturing, assembly, packaging, and sterilization—allows us to bring our customers’ healthcare solutions to market. We have facilities across the U.S. and around the world, including low-cost facilities in Costa Rica, China, Mexico, and Puerto Rico.

Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.