Quality Document Control Specialist: DHR & CAPA Expert

The Panther Group; West Boylston (MA); On-site; USD 33,000 - 40,000; Full time

Job summary

The role requires attention to detail, strong organizational and communication skills, and 2+ years of office experience in a medical device environment. Proficiency with Omnify Training module and electronic document systems is a plus. Occasional cross-training in other quality areas is expected.

Qualifications

• High School Diploma or GED required; some College education preferred.
• 2+ years of office experience, preferably in a medical device manufacturing organization.
• Proficient in MS Excel, Word, PowerPoint, MS Project; ERP and Omnify familiarity a plus.
• Strong communication and interpersonal skills; detail oriented and organized.

Responsibilities

• Maintain and review Device History Records (DHRs) ensuring signatures and data are complete.
• Scan DHRs, save electronically, and upload to FTP sites; enter documents into electronic systems.
• Assist with creation, update, and processing of procedures, work instructions, and quality documentation.
• Coordinate training, prepare training curricula, and manage training records in Omnify.
• Assist with CAPA administration, quality metrics, audits, and Notified Body activities.

Skills

Attention to detail

Organizational skills

Customer service

English proficiency

Teamwork

Communication skills

Education

High School Diploma or GED

Some college education preferred

Tools

MS Excel

MS Word

MS PowerPoint

MS Project

ERP

Omnify Training module

Job description

The role requires attention to detail, strong organizational and communication skills, and 2+ years of office experience in a medical device environment. Proficiency with Omnify Training module and electronic document systems is a plus. Occasional cross-training in other quality areas is expected.