Quality Engineer

Instant Systems•Norfolk, VA

33d

About The Position

We are seeking a highly motivated, hands on and detail-oriented Quality Engineer to join our team. This role is responsible for developing, optimizing, and maintaining manufacturing processes to ensure high-quality production of single use supplies including medical device components. The ideal candidate will have hands-on experience in a manufacturing environment, with a strong background in process engineering, lean manufacturing, and quality systems within a regulated industry.

Requirements

Ability to write reports, business correspondence, and create project plans.
Ability to effectively present information and respond to questions from the customer and/or management.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Bachelor’s Degree and minimum 4 years of prior relevant experience. Graduate Degree and a minimum of 2 years of prior related experience. In lieu of a degree, minimum of 8 years of prior related experience.
Knowledge of plastic materials a plus
Practitioner of scientific method
Proficient knowledge of ISO based Quality Management Systems.
Mechanical engineering experience preferred
Knowledge of Quality Engineering and Advanced Quality principles (Six Sigma methodology, Root Cause/Corrective Action, DMAIC, Design for Manufacturability).
Proficient in understanding of engineering drawings, documentation, including dimensioning, and tolerance.
Experience working with project management and interfacing with customers.
Legal authorization to work in the U.S. and not require employment-based sponsorship now or in the future.

Nice To Haves

enjoy an autonomous work environment.
have a LEAN mindset.
are the first person to help.
seek out opportunities to bring added value.

Responsibilities

Knowledge and experience with quality tools, such as CAPA, six sigma, lean manufacturing, PPAP, FMEA, problem solving techniques, and root cause analysis.
Participate in APQP and NPI activities
Lead, document, and track FMEAs
Responsible for coordinating suppliers and verifying quality standards in accordance with industry and customer requirements
Develop and implement supplier management programs
Identify technical problems as well as cost reductions with suppliers
Manage Supplier corrective actions
Provide quality support in all aspects of the Product Life Cycle (design & development, qualification, testing, release to production and release to customer)
Conduct quality investigations (CAPA and NCR) and Material Review Board (MRB)
Coordinates activities between cross-functional teams in support of FRACAS (Failure Reporting and Corrective Action System).
Drives root cause corrective actions (RCCA) for quality issues
Utilizes and implements systematic RCCA and Six Sigma methods, tools, and techniques.
Supports 3rd party, customer, internal and external audits
Supports inspection and ensures compliance of engineering (formal and dry run) verification, acceptance, and qualification tests
Define Quality Standards, Identify Critical to Quality (CTQ) requirements and apply Key Process Indicators
Develops Quality Assurance Plans with the participation of cross-functional teams.
Position requires allocation of varied assignments, projects, challenges and other tasks as assigned.
Authors validation protocols and reports