Quality Systems Associate

Corvia Medical, Inc., located in Tewksbury, MA, is a well-funded medical device start-up dedicated to revolutionizing the treatment of heart failure with first-in-class structural heart devices.

We are looking for a Quality Systems Associate to join our growing team. The Quality Systems Associate is responsible for supporting the Document Control and Quality System functions at Corvia Medical. This position helps to ensure efficient and compliant systems and that only the highest quality products are released to our customers.

Key Responsibilities:

• Support Quality Systems Administration in maintaining compliance with ISO 13485 and cGMP’s. Includes but is not limited to the following systems and records: Design History Files, Training; NCMR; CAPA; Deviation; Lot Release; Supplier Management; Internal Audit; Device History Records, and Document Control systems.
• Support processing of Engineering Change Orders, scan/convert document format as required, and file changed documents. Distribute controlled copies of applicable documents to point of use. Move obsoleted documents to proper file(s).
• Check all records upon receipt for proper completion, scan as required, and properly electronically file the scanned records.
• Approval and filing of Device History Records from Incoming Inspection thru Positive Lot Release, including inventory cards. Ensure documentation is complete and accurate before filing.
• Maintain on-line metrics files, activity logs, and databases, both in MS Excel and MS Access.
• Create file folders for new documents as required.
• Generate metrics and reports for Management Review and trending.
• Provide Quality Orientation Training to New Hires. Maintain Training Records.
• Assist others in document retrieval and refiling as requested.
• Other duties as assigned.

Requirements:

• AS/BS Degree
• A minimum of 1-3 years’ work experience in a medical device company, with exposure to the Document Control/Quality System or related discipline desired.
• Demonstrated working knowledge of Microsoft Word, Excel, & PowerPoint. MS Access exposure desired.

Skills/Competencies:

• Effective verbal and written communication skills required.
• Good editing, punctuation, grammar skills is an absolute must.
• Expert at maintaining organized, complete, and accurate records.
• PC, word processing, scanning, filing skills required.
• Must possess an excruciating attention to detail.
• Perfectionists are desired.

Corvia offers a competitive salary and benefits package.

Corvia Medical, Inc. is an Equal Opportunity Employer.

Job Type: Full-time