Job description

GENERAL DESCRIPTION:
The Quality Engineer is responsible for providing quality assurance knowledge and hands-on support for all aspects of production operations, quality control activities and new product launches 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, the Quality Engineer will be the owner of: quality planning; validations; FMEA and risk analysis; capability studies; 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 Document Change revision, reviews and approval
• Participate in cross-function team for new product, develop and create process validation protocols and reports; analysis of data inspection and metrology data, develop quality documentation and train Quality Lab accordingly, and ensure supplier quality requirements are established
• Participate in manufacturing review (contract review) and new product testing to ensure quality compliance and that all products meet or exceed customer requirements
• Monitor (by performing process capability and performance studies); recommend improvements (to processes, procedures and systems) 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); write 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
• Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
• Effectively communicate and interact with customers.
• Acts as a lead in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
• 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
• 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 assigned

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; willing to learn and take on new responsibilities/tasks
• 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

EDUCATION

• Bachelor’s degree in engineering, preferably in manufacturing or plastics Engineering.
• 2 years college degree in a technical discipline with 10 years of working 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
• This position requires less than 10% travel

CONDITIONS AND ENVIRONMENT
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 chemical

Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn. 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.

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