Document Control Coordinator II

Description

The Document Control Coordinator II supports Operations, R&D, RA, and QA activities by preparing, reviewing, routing, approving, archiving and implementation of Quality System documents.

Responsibilities

• Perform Document Control preparation, review, routing, approval, and archiving of Quality System documents according to established Procedures/Work Instructions.

• Manage hardcopy and digital Quality System files.

• Ensure SolidWorks drawings and part/assemblies links are maintained with each document revision.

• Update and maintain Document Control related logs and ERP system.

• Help ensure compliance to FDA and ISO 13485 compliance.

• Collaborate with training administrator to ensure pending training items are met.

• Assist in reviewing established processes and suggest process improvements.

• Support other departments with process and system questions related to Document Control.

• Assist with lab notebook issuance.

• Scan and log paper records to create electronic records (DHRs, RIRs, etc.) and box hard files to send to off-site storage.

• Perform additional duties as assigned.

Qualifications

• Minimum 4 years' Document Control experience or 4-year college degree.

• Ability to follow-up on pending action items to ensure timelines are met.

• Proficient in the use of Microsoft Word and SolidWorks.

• Must be self-auditing and have high quality standards.

• Attention to detail.

• Able to work independently with minimal supervision.

• Possess strong interpersonal skills.

• Must be able to read, understand and relay technical information accurately and concisely.

Inari Medical offers competitive health and wealth benefits for our employees. The base pay range for this position is $28.00 - $35.00. A range of factors, including location, skills, and experience, will be considered. Actual compensation may vary.

Inari Medical, Inc. advises applicants that employment is subject to completion of a successful background check.