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Quality - Quality Engineer
Company | Viant Medical |
Address | South Plainfield, NJ, United States |
Employment type | CONTRACTOR |
Salary | |
Category | Medical Equipment Manufacturing |
Expires | 2023-06-30 |
Posted at | 10 months ago |
General Description
- 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
- 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
- Provide quality support and representation for cross-functional initiatives and projects
- Participate in manufacturing review (contract review) and new product testing to ensure quality compliance and that all products meet or exceed customer requirements
- 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.
- Represent Quality Document Change revision, reviews and approval
- 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
- Ensure that all documentation is completed in a timely manner and follows established policies, practices, and procedures
- 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
- Follow and ensure that all personnel comply with FDA regulations, ISO standards, customer requirements, and SOPs as defined by Viant’s policies and procedures
- Perform other duties as assigned
- Lead or support by providing Quality representation for internal and external audits and customer visits
- 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.
- Provide training on new or updated manufacturing processes or procedures
- Investigate customer complaints including root-cause analysis; develop and implement corrective action plans; document findings, and communicate with customers
- 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
- Well organized; able to multi-task, prioritize, and manage multiple deliverables while working in a fast-pace environment
- 3+ years of work experience in a Quality Engineering role or equivalent experience
- Familiar with geometric dimension & tolerance (GD&T) procedures and requirements
- Highly motivated, focused, self-starter; willing to learn and take on new responsibilities/tasks
- Experience in medical device manufacturing preferred but not required
- Experience in contract manufacturing and/or manufacturing environment preferred but not required
- Problem-solving skills and critical thinking
- Experience working in a regulated environment (ISO 13485, 21 CFR 820, or other) preferred but not required
- Advanced computer capabilities including Microsoft Office software
- Able to read and interpret blueprints
- Strong interpersonal, written, and oral communication skills
- Injection molding experience preferred but not required
- Quality-driven customer service
- Able to work individually and as part of a team
- 2 years college degree in a technical discipline with 10 years of working experience.
- Bachelor’s degree in engineering, preferably in manufacturing or plastics Engineering.
- 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
- Preparing and analyzing data and figures
- 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
- Viewing a computer screen
- Transcribing
- Using measurement devices
- Assembly or fabrication of parts at distance close to the eyes
- This position does require moderate amounts of walking, standing, bending, kneeling, stooping, pushing, pulling, reaching, lifting, and twisting
- Extensive reading
- Visual inspection involving small defects, small parts, and/or machine operation
- Worker is required to have close visual acuity to perform activities such as:
- This position requires less than 10% travel
- Inside environmental conditions: Protection from weather conditions but not necessarily from temperature change
- Vibration: Exposure to oscillating movements of the extremities or whole body
- Noise: Sufficient noise to cause a worker to shout in order to be heard above ambient noise
- 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
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