PLS Reedsville MFG Slry - Engineer, Quality

Jadex•Reedsville, PA

2d•Onsite

About The Position

Provide Quality system support through internal and external customer engagement. Lead and support continuous improvement for product and processes. Support plant functional areas such as engineering, operations, and maintenance by conducting data and document review/approval as it pertains to the plant quality control systems. Support investigation and root cause analysis, CAPA, documentation management, and change management.

Requirements

Bachelor’s degree in engineering or related scientific discipline.
Three to Five (3-5) years of experience working in Quality Assurance of a manufacturing facility.
Desired minimum of 2 years’ experience in a cGMP compliant environment or ISO certified industry.
Specifically; ISO 13485, 21 CFR 820, and 21 CFR 210 & 211.
Experience in SPC, sampling/auditing/reading blueprints, dimensioning and tolerance.
Practical and direct experience utilizing continual improvement and quality tools to include control charts, capability studies, DOE, regression analysis, histograms and fishbone charts.
Experience with Corrective Action & Root Cause Analysis / Preventive Action / Continual Improvement.
Able to effectively communicate and interface with customers via written, verbal, or personal means in order to ensure a clear understanding of all requirements.
Experience with Minitab.
Experience writing protocols and reports; a demonstrated ability to write technical protocols, analyze information, and report results.
Experience with risk management techniques/tools.
Experience with the use of quality systems software to manage investigation, CAPA documentation, batch data, and change control.
Continual demonstration of professional development and the application to plant activities.
Effective presentation/communication skills, both oral and written, project/resource management skills.
Interpersonal skills required to communicate in accurate manner to individuals and to the team to develop a cohesive group.
Ability to lead project teams consisting of members with diverse roles and backgrounds.
The ability to work with and maintain information of a highly confidential and sensitive nature.

Responsibilities

Aides in ensuring regulatory and standards compliance as applicable during project management and transition to manufacturing, assuring customer specification and inspection methods are understood and complied with throughout engineering projects into production.
Assists as necessary in the development and execution of procedures for product and equipment Process Validations.
Conducts and participates in audits as necessary.
Serves as support to metrology improvement and needs for the laboratory team.
Works independently and with project teams to develop design control deliverables including quality plans, manufacturing & inspection documentation (SOPs, Work Instructions), test methods, and any other necessary documentation.
Supports the QMS through review and approval of product / process investigations (deviations, OOS), change control, CAPA, and other quality systems documentation as necessary.
Assists in the management of quality metrics/KPIs and their review through trend analysis and interpretation.
Leads and supports root cause failure analysis and implementation of corrective and preventive actions to preclude reoccurrence.
Primary support to plant continuous improvement by evaluating products, processes, or materials to develop control or improvement strategies intended to improve the internal and customer experience.
Other duties as assigned.