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Stryker Group in Irvine, CA is seeking a hands-on technical support specialist for manufacturing process development, equipment installation and validation, and the documentation needed to launch and sustain production processes.
You will partner with Engineering and Operations to troubleshoot, support continuous improvement, and ensure GMP, GDP, and safety compliance, focusing on readiness through process stabilization and training.
This role provides hands‑on technical support for manufacturing process development, equipment installation and validation, and documentation required to successfully launch and sustain production processes. The position partners closely with Engineering and Operations to troubleshoot issues, support continuous improvement initiatives, and ensure compliance with quality, GMP, GDP, and safety requirements. A key focus of this role is supporting production readiness through process stabilization and training during new process implementations.
Develops and recommends procedures and methods and prepares technical reports and documentation.
Performs technical evaluations of events to determine root cause and recommends corrective action.
Actively interface with cross-functional team members always practicing good teamwork in support of day to day operating requirements.
Monitoring and management of manufacturing loss on assigned lines.
Liaising with Team Leaders with regard to productivity and efficiency performance issues on assigned lines.
Diagnose malfunctioning systems to identify hazards, defects and the need for adjustment or repair and escalation as required.
Communicating regularly with Operators regarding issues, concerns and watch‑outs on the lines.
Responsibility for product line performance, primarily maximizing productivity of the equipment and minimizing yield loss from the process.
Identifying and assisting the engineering with the implementation of technical improvements and process improvements.
Adherence to Environmental Health & Safety (EHS) requirements on sites, plus communication of any concerns regarding environmental impact, health or safety issues.
Building of Quality into all aspects of one’s work by maintaining compliance with all site and corporate Quality Management System requirements
Support to the business as required by management or as mandated by shutdowns and/or equipment/process failures.
All other duties as assigned.
High School diploma or equivalent required.
Requires 2 years of relevant experience.
Must possess excellent organization and communication skills.
Proficiency with Microsoft Office applications
Prior experience working in a manufacturing and/or regulated environment.
Demonstrated ability to lay out and set‑up machines as well as product inoculation.
Demonstrated ability to inspect product with the use of all standard inspection tools.
Demonstrated communication and interpersonal skills, with the ability to work successfully in a team‑based environment that heavily emphasizes quality, performance, and accountability.
$32.22 - $44.57 USD Hourly