Quality Document Control & Training Coordinator

Polyzen; Apex (NC); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Generous Paid Time Off

Annual Bonus

401(k) with match

Health Insurance

Disability insurance

Job summary

Polyzen is a leading developer and manufacturer of customized polymer-based materials, films, components, and assemblies for the medical device industry. Our range of materials and processing technologies allow us to provide optimum solutions for innovation-driven companies, ranging from entrepreneurial start-ups to major medical device manufacturers.

As the Document Control & Training Coordinator, you will ensure the effectiveness and compliance of the document management system and training

Qualifications

• ISO and FDA-regulated environment experience.
• Experience developing or maintaining a QMS or controlled document system.
• Proficient with MS Office and able to create and edit SOPs/WIs.

Responsibilities

• Implements and maintains the QMS documentation system and associated processes.
• Monitor Change Control Request process and ensure WI compliance.
• Author/update controlled documents and specifications (SOPs, WIs, Internal Specifications).
• Ensure quality records are controlled and retained.
• Initiate periodic review of controlled documents.
• Manage training program and maintain training records; conduct orientation for Quality.
• Assist in audits and supply documents as needed.
• Provide metric data as requested.
• Maintain off-site storage of records.

Skills

Communication

Prioritization

Attention to detail

Independent work

Teamwork

Education

High School Diploma or GED

Tools

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Job description

Polyzen is a leading developer and manufacturer of customized polymer-based materials, films, components, and assemblies for the medical device industry. Our range of materials and processing technologies allow us to provide optimum solutions for innovation-driven companies, ranging from entrepreneurial start-ups to major medical device manufacturers.

As the Document Control & Training Coordinator, you will ensure the effectiveness and compliance of the document management system and training