Quality Engineer
Company: Synerfac Technical Staffing
Location: Buena
Posted on: April 5, 2021
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Job Description:
Engineer
Quality Engineer
Manufacturing Engineer
Our client located in South Jersey is currently looking for an
Engineer to join their Quality Team. The company supports the
Pharmaceutical industry and is rapidly growing and looking to fill
multiple positions within the company. Please review the
information below and if you feel you have the experience our
client is looking for and would like to hear more about the
opportunity please apply.
Operational Quality Improvement
* Execute pilot program activities directed by Quality Systems
Manager supporting Operations Manager* Ensure compliance to program
checklist activities and lead corrective actions for errors*
Understand and communicate the performance and quality gains from
strict adherence to best practices.* Collaborate cross-functionally
to create necessary QMS documents (WIs, PMs, SOPs, Forms)* Ensure
understanding and training to responsibilities within the plant
Quality Department.
Quality Management System (QMS) Support
* Follow applicable requirements of FDA cGMP, ISO 13485, ISO 9001,
ISO 14971, FDA 110/210/211, GFSI, Process Validation et. al.*
Create, review, and approve validation IQ/OQ/PQ/PPQ protocols and
reports.* Analyze and summarize data for validations, CAPA, and
other quality initiatives* Internal Auditing of adherence to
procedures* Manage the Visual Factory Layered Process Audit process
and report out on deficiencies and actions* Monitor impact of
plant-floor, process or setting changes on the validated state of
the lines* Create, modify, and approve (with other SMEs) deviations
and change control requests for documents, equipment, and
processes* Track open deviations and change controls for proper
closure and resolution.
Investigate Customer complaints, Non-Conformance Report (NCR),
Corrective and Preventive Action (CAPA), and lead Continuous
Improvement
* Use critical thinking and problem-solving skills to determine
root causes of issues (5 Why, Fishbone, 8D, Is/Is-Not).* Lead
and/or facilitate Operations and Quality cross-functional
investigations. Determine corrections, corrective actions, and
verification of effectiveness.* Analyze data and trends within the
CAPA process to determine systemic risks.* Lead corrective action
effort for systemic risks.* Document investigations and
improvements using analysis of data (ANOVA, Cpk, Trending, etc.)*
Identifying opportunities for Continuous Improvement, defining
value and implementation.
Job Requirements WE ARE LOOKING FOR:
* Bachelor"s degree completed for technology, engineering, science
or significant applicable experience, training, and
certifications.* 2+ years" experience in Manufacturing or Quality
Engineering.* Experience with Technical writing of reports, data
analysis, customer response correspondence, and procedure
manuals.
Preferred:
* Experience working in medical device or food manufacturing
environments.* Experience with visual inspection standards and
processes.* Experience with performing training for plant-floor
personnel.* Experience with the validation of manufacturing and
inspection processes.* Knowledge of the safety requirements and
complexity of working with automated and semi-automated production
and inspection systems in a factory environment.* Knowledge of
vision inspection systems, and PLCs (programmable logic controllers
for factory automation) preferred.* Knowledge of lean manufacturing
principals in a high volume and high complexity environment.*
Knowledge of injection molding and plastic assembly processes.
Keywords: Synerfac Technical Staffing, Camden , Quality Engineer, Engineering , Buena, New Jersey
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