Job Title: Quality Associate - (Doc Control)

Job Description

We are seeking a diligent Quality Associate with expertise in document control to join our team. The role involves updating logs, databases, and catalogs of product, manufacturing, and regulatory compliance information. The successful candidate will coordinate the review and revision of procedures, specifications, and forms, prepare process and status reports, assign and monitor document numbers, and review documents for accuracy and completeness. Additionally, the role includes assisting in compiling regulatory filing documents and maintaining computerized files to support all documentation systems.

Responsibilities

• Update logs, databases, and catalogs of product, manufacturing, and regulatory compliance information.
• Coordinate the review and revision of procedures, specifications, and forms.
• Prepare process and status reports, assign and monitor document numbers, and review documents for accuracy and completeness.
• Assist in compiling regulatory filing documents and maintaining computerized files to support all documentation systems.

Essential Skills

• Quality assurance
• Medical device knowledge
• Document control
• Change control

Additional Skills & Qualifications

• 1-2 years of experience in a similar role
• University degree or extensive practical knowledge gained through experience
• Attention to detail in making evaluative judgments based on the analysis of factual information

Work Environment

This is an individual contributor role that requires the use of judgment in applying professional expertise and is expected to work independently with minimal supervision. The job requires an understanding and application of procedures and concepts of one's own discipline. The position offers 2 weeks of PTO and 10 paid holidays.