The Quality Engineer is responsible for supporting, creating and maintaining key elements of the Quality Management System (QMS) for the Moorestown facility. The QMS includes investigation and CAPA management training, internal and external audits, customer correspondence, validation, documentation control and includes quality assurance of the operation such as process monitoring and batch record review and release.
This position reports to the Quality Manager and is responsible for the development of product specifications, data collection systems, line audit creation, developing answers to internal and external complaints and creation of cross functional SOPs.
QE candidates should have 3-5 years minimum of Quality Engineering background, preferably in the Packaging / Pharmaceutical industry, GMP experience and a degrees in Mechanical, Industrial, Quality and/or Chemical Engineering.
Assures adequate internal quality standards are in place.
Leads the problem solving efforts for all quality complaints. Oversees the tracking, completion and effectiveness of corrective actions.
Responsible for process and equipment validations (new/ relocated) - experience in DQ / IQ / OQ / PQ activities
Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
Establishes statistical confidence by identifying sample size and acceptable error; determining levels of confidence.
Develops sampling plans by applying attribute, variable, AQL and sequential sampling methods.
Prepares reports by collecting, analyzing and summarizing; making recommendations.
Contributes to team effort by accomplishing related results as needed.
Designs and implements quality assurance systems consistent with industry standards that increase quality levels.
Serves as primary trainer for various portions of quality programs and initiatives.
Performs all other duties as assigned.
Comply with all safety policies, practices and procedures with a goal of no injuries/accidents.
Responsible for assisting in achieving plant wide safety goals.
Responsible for maintaining a clean work environment and conducting a daily 5S audit of work area.
Report all unsafe activities immediately to supervisor or human resources.
III. Position Requirements:
Bachelor’s Degree in Engineering, Statistics or Quality-Related or equivalent work experience.
Three to Five years of experience in Quality Assurance minimum
CQE and Six Sigma Certifications preferred.
Proficient with Microsoft Office.
Experience in Pharmaceutical industry preferred.
Experience in Printing industry preferred – cartons, inserts.
Proven track record of improving quality, efficiency and workflow in a production environment.
Personal and professional development history with strong communication skills – written and verbal / Customer interaction.
Leadership skills: Lead by example; take charge; good judgment; decisiveness; provide direction; coach/develop.
Manufacturing: Process improvement; material flow and process flow; performance measurement; lean manufacturing concepts.
Pharmaceutical packaging safety: OSHA.
Diversity: Multi-cultural work environment.
IV. Physical Demands:
Individuals will need to sit or stand as needed. May require walking primarily on a level surface for periods throughout the day. Reaching above shoulder heights, below the waist or lifting as required to file documents or store materials throughout the workday. Proper lifting techniques required. May include lifting up to 25 pounds for files, computer printouts on occasion. Position may experience periods of frequent overtime on weekdays and weekends.
V. Work Environment:
The performance of this position may occasionally require exposure to the manufacturing areas where the use of personal protective equipment such as hearing protection may be required. Requires the removal of personal items such as jewelry, rings, bracelets, watches, necklaces, and earrings. Primary environment: ambient room temperatures, lighting and traditional office equipment as found in a typical office environment.
About Essentra PLC - Moorestown NJ
Essentra is a leading global provider of packaging and authentication solutions to a diversified blue-chip customer base in the pharmaceutical, health & personal care, consumer and specialist packaging sectors, and to the paper and board industries. The business focuses in delivering value-added innovation, quality and service through the provision of a wide range of products and solutions, including cartons, tapes, leaflets, foils, labels and authentication solutions.
This position is available in the Moorestown, NJ location which is part of Essentra's Packaging sector.