Change Control Coordinator II

The Change Control Coordinator II will be a key contributor to the quality organization and heavily influence the overall quality of the ZincFive document and change control processes. The Change Control Coordinator II is responsible for leading, establishing and maintaining a documentation and engineering change control management system capable of meeting quality, regulatory and company requirements. This position reports to the Quality Management System Manager and will work onsite at ZincFive headquarters in Tualatin, Oregon., * Leading and organizing the change control function for both Engineering and QMS document changes

• Assists with the deployment and maintenance of electronic quality management system
• Assists in the development of document classifications to facilitate information storage and retrieval
• Assist managers and others in creating training curricula, materials, documentation
• Receive, file, and maintain all documents, including but not limited to procedures, work instructions, test methods, specifications, incident reports, CAPAs, Product Complaints, in the electronic quality management system
• Manage quality management system that tracks the receipt, revisions and archiving of all ZincFive documents
• Oversee and administer document lifecycle management the document change request process
• Oversee and administer the product lifecycle management of the engineering change request process
• Assist in the maintenance of training records and documentation within our quality management system
• Perform and document internal audits

Do you have experience in Regulatory compliance?, Do you have a Bachelor’s degree?, * Bachelor’s degree in Business or equivalent experience

• 5-10 years of experience in a related field
• Experience with an electronic quality management system
• Good organizational, project management skills and ability to perform varied tasks in a disciplined, consistent manner
• Ability to analyze, interpret technical procedures and regulations
• Quality Assurance experience, including the ability to identify and resolve document control and training compliance issues
• Strong computer skills including Microsoft Office and databases
• Ability to work under pressure in a fast, changing, and small startup company environment

Preferred Experience/Skills:

• Relevant certifications such as a Quality Auditor
• Knowledge of relevant regulatory requirements such as UL, IEEE, ISO 9000/9001
• Knowledge of/experience using Quality Management System Software
• Knowledge of/experience using SAP or other CRM/ERP applications
• Technical writing skills

Key Competencies:

• Planning and organizing
• Excellent communication skills - verbal and written
• Attention to detail
• Good judgment
• Solid decision-making
• Customer service oriented
• Teamwork

Physical Requirements and Working Conditions:

• Work involves sitting, walking, and lifting to 35 pounds
• Requires close visual acuity, the ability to distinguish color, and the ability to hear
• Warehouse and office environment

Salary offers will depend on factors that include the location you work from, your level, education, training, specific skills, years of experience and comparison to other employees already in this role.

Pulled from the full job description

• 401(k)
• Health insurance
• Paid time off
• Vision insurance
• Dental insurance
• Paid sick time
• Life insurance, In addition, the successful candidate for this position will become eligible for a comprehensive set of outstanding benefits, including medical, dental, vision, life insurance, 401k, paid sick time, paid time off for vacation, paid holidays, paid community service days, professional/personal learning program, and applicable state/federal paid family leave.