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Job Details

Skills

IQ
OQ
PQ
Root Cause Analysis
Problem Solving
Conflict Resolution
Presentations
Billing
Product Lifecycle Management
Plant Lifecycle Management
Process Improvement
Machining
Data Analysis
Minitab
Process Engineering
Technical Writing
Management
Medical Devices
Manufacturing
Communication
Microsoft Office

Summary

Roles & Responsibilities

Write and execute validation protocols and reports (IQ, OQ, PQ).
Develop and implement manufacturing processes, specifications, operator instructions, process studies, and production readiness activities.
Conduct investigations, root cause analysis, problem solving, and prepare reports/presentations.
Update procedures, manufacturing specifications, bills, routes, and travelers for product/process changes in PLM systems.
Work with equipment manufacturers and distributors to develop user requirements.
Partner with Operations, OpEx, Planning, Engineering, and Quality teams to align validation strategy, author documents, coordinate execution, and manage approvals.
Ensure adherence to FDA regulations, regulatory requirements, company policies, and operating procedures.
Identify opportunities for process improvement and implement best practices.
Maintain positive and cooperative communication with employees, customers, contractors, and vendors.
Background in medical device or other regulated industries.
Experience with machining, metal finishing, laser processing, or production automation.
Practical exposure to machining, casting, finishing, laser processing, or automation.
Knowledge of statistical data analysis tools (e.g., Minitab).
Basic understanding of Geometric Dimensioning and Tolerancing.
Willingness to support global projects, including travel.

Requirements:

2-4 years of experience in manufacturing and/or process engineering.
Strong technical writing skills with awareness of intended audience.
bility to effectively communicate with operators, peers, and management in both written and oral formats.
Handson experience with validation protocols.
Experience in medical device and/or regulated manufacturing environment.
Interpersonal Skills:
Persuasive communication and strong interpersonal abilities.
Proficiency with Microsoft Office tools.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 62f7aeac46daf456541d07a10e65bb8c
Posted 30+ days ago

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