Medegen Medical Products · 13 hours ago
6A11 - Extrusion-roll - PCE1 - PROCESS ENGINEER I
13 Industrial Park Rd, Lewistown, PA 17044, USA
Full-time
Onsite
Mid, Senior Level
3+ years expMedegen Medical Products is focused on supporting production goals and quality assurance for Trinity Plastics. The Process Engineer will develop new processes and formulations, oversee trial runs, and provide technical support to various teams while ensuring compliance with quality management systems.
Health CareManufacturingMedical
Responsibilities
New process/product formulation development, while providing product quality assurance
Lead existing process/product formulation improvement projects
Oversee trial run process and approve trial run samples as needed
Approve product specification, formulation and quality standard setup
Approve raw material and masterbatch selection and qualification
Complete and authorize resin compliant reports
Respond to customer complaints
Provide technical support service and support to customers, production and marketing teams
Provide trouble shooting assistant to the production team
Ensure technical updates and regulation mandates are current
Performance evaluation through daily and annual review of the Quality Department process and procedures and of the team
Communicate with raw material vendors for new resin selection, existing resin improvement and troubleshooting resin discrepancies
Serve as a management representative during ISO/SQF/GMP, Social Compliance certifications for the company
Ensure that quality management system processes needed are established, implemented and maintained
Report to top management on the performance of the quality management system and advice management of improvements needed
Assist with procedure writing for documents that describe all of the shall requirements in the ISO/SQF/GMP standard and what must be maintained implemented, defined and determined
Carry out any special project assigned by IBS Division President/ IBS General Manager
Research, resolve, and document customer complaints
Maintain customer complaint samples and competitor samples
Safely comply with all plant safety rules and procedures
Qualification
Required
Bachelor Degree with 3 years' experience in the plastics industry
Proficient working knowledge of all Microsoft Programs
Minimum three years of Quality Assurance and supervisory experience
Good problem-solving and project management skills
Good oral and written communication skills
Ensure consistent, dependable attendance and demonstrate a willingness to accommodate non-standard work hours as necessary
Capable of effectively managing job-related stress and fostering productive workplace interactions
High degree of communication ability, both oral and written to both managers and plant personnel
Good interpersonal skills
Design of experiment knowledge a plus
Good attendance record
Possess certification in quality management system auditing
Proficient statistical and analytical skills
Ability to differentiate color
Company
Medegen Medical Products
Medegen Medical Products is a Medical Products Manufacturer, based in Gallaway, TN and Clarksburg WV.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Denny Guest Jr
Vice President National Accounts, Strategic Partner Development
Recent News
Medical Product Outsourcing
2025-04-21
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