Job Description

****HYBRID****

This function will be directly supporting the EUMDR project on Site.

Responsibilities

• Periodically work independently with vendors.
• 2D drawing & GD&T knowledge or experience.
• Create and manage Engineering Change Requests as well as product impact assessments.
• Manage Engineering Change Notices for process changes from creation to final approval
• Demonstrate a general understanding of Product Part Approval Process (PPAP)
• Demonstrate a general understanding of First Article Inspection (FAI) process
• Periodically lead projects and processes; work with cross-functional teams to get these projects completed. Ability to multi-task between different projects and changes.
• Investigate Quality issues for root cause and recommend/implement corrective actions.
• Ability to oversee team members workload and provide support when issues arise.
• Work to support team members as both mentor/mentee when necessary.

Requirements:

Education and Special Training Required: Bachelor’s Degree in Engineering or relevant field of study

Qualifications and Work Experience Required

• 1-3 years’ experience in a production/manufacturing environment.
• Demonstrated computer skills using Microsoft Office applications (Word, Excel, PowerPoint, Project, etc), and experienced work in a Quality Management System and UDI/MDD/MDR/UKCA Regulatory Compliance project experience is preferred.
• Demonstrated interpersonal, communication and presentation skills. Must be comfortable presenting at team level meetings and lead meetings as necessary.
• Demonstrate strong teamwork and time management skills as well as be able to operate in a fast-paced environment.
• Ability to perform in and be challenged by a multi-disciplinary team-based environment, which places a high degree of emphasis on accountability for quality/GMP/GDP compliance.
• Provide technical support for quality control, process improvement, equipment qualifications, and process validations.
• Operate within Stryker’s quality management system (QMS) to produce and/or review documentation such as, inspection guide sheets, product drawings, dynamic control plans (DCPs), and standard operating procedures (SOPs)

Job Tags

Similar Jobs