Quality Associate

Overview

Quality Associate Jobs in Baltimore, MD at Longeviti Neuro Solutions

Title: Quality Associate

Company: Longeviti Neuro Solutions

Location: Baltimore, MD

Company

Longeviti is a medical technology company advancing neurosurgical care through the ClearFit® platform, a Brain Ultrasound Interface (BUI) platform that enables ultrasound imaging through sonolucent cranial implants. Longeviti works with neurosurgeons, academic medical centers, and clinical research collaborators to generate evidence supporting safer, more efficient postoperative monitoring for patients with neurological disease.

Location

Baltimore, Maryland preferred. In-person or in-office presence is strongly preferred. Hybrid arrangements may be considered for exceptional candidates, with travel to participating clinical sites as needed.

Position Summary

The Quality Associate is primarily responsible for executing comprehensive Quality Assurance (QA) product inspections on Longeviti Neuro Solutions' in-house manufactured Clearfit™ custom cranial implants and Clearfit™ off-the-shelf standard cranial implants. This individual plays a critical role in ensuring that every product shipped to patients and surgeons meets or exceeds Longeviti’s rigorous quality standards and fully complies with the company’s Quality Management System (QMS) and applicable FDA regulations. The Quality Associate works cross-functionally with manufacturing, order fulfillment, and engineering teams and partners closely with the Compliance Manager to maintain and continuously improve quality documentation and processes.

The position is designed to provide foundational experience in medical device quality systems, with opportunities to grow into broader quality responsibilities such as CAPA support, auditing, and process improvement.

Essential Duties and Responsibilities

The following duties are representative of this position. Other duties may be assigned as needed.

Product Inspection & Quality Assurance

· Perform in-process and final inspections on all Clearfit™ custom and standard cranial implants to verify conformance to applicable drawings, specifications, and acceptance criteria.

· Conduct incoming inspection of raw materials, components, and purchased parts; document results and disposition nonconforming materials per established procedures.

· Utilize hand tools (calipers, micrometers, gauges, etc.) and automated measurement systems to perform dimensional and visual inspections.

· Review and verify product work travelers documentation, both paper and digital, for completeness and accuracy prior to product release.

· Identify, document, and initiate nonconforming product reports (NCRs); participate in root cause analysis and corrective action activities.

· Support first article inspection (FAI) activities for new or revised products.

Quality Documentation

· Maintain accurate and complete quality records in compliance with company procedures and regulatory requirements

· Assist with updates and revisions to SOPs, Work Instructions, and quality forms

· Ensure proper document control practices are followed

Quality Metrics & Reporting (Support Role)

· Collect and compile inspection and quality data

· Support tracking of quality metrics such as defect rates and NCR trends

· Assist with preparation of reports and basic data analysis in Excel

Cross-Functional Collaboration & Compliance

· Collaborate with manufacturing and engineering to address quality issues

· Support internal audits and audit preparation activities

· Assist with CAPA investigations by gathering data and documenting findings

· Provide backup support for order fulfillment activities as needed

Education and Experience Requirements

One of the following combinations of education and experience is required:

· Option 1: Bachelor’s degree (4-year) in Engineering, Science, or a related technical field, plus 0-2 years of quality assurance or quality control experience in a regulated manufacturing environment.

· Option 2: Associate’s degree (2-year) in a technical discipline plus 4-7 years of quality assurance or quality control experience in a regulated manufacturing environment.

· Option 3: No degree required with a minimum of ten (10) years of progressive quality assurance or quality control experience in a regulated manufacturing environment.

Experience in the medical device industry and with FDA-regulated quality management systems is strongly preferred.

Required Knowledge, Skills, and Abilities

· Basic understanding of quality systems (FDA, ISO 13485 preferred)

· Ability to read and interpret engineering drawings (GD&T exposure preferred)

· Familiarity with measurement tools and inspection techniques

· Proficiency in Microsoft Excel (basic formulas, data entry, charts)

· Strong attention to detail and organizational skills

· Ability to follow procedures and work independently with guidance.

GROWTH PATH

This role is intended to develop into expanded responsibilities in:

· CAPA and root cause analysis

· Internal auditing

· Process validation and improvement

· Quality engineering support

.

Work Environment and Physical Requirements

· Work is performed in a manufacturing and office environment; may require periods of standing on the production floor.

· Must be able to use fine hand tools and measurement instruments requiring manual dexterity.

· May require occasional use of personal protective equipment (PPE) per area-specific requirements.

· Regular use of a computer workstation for documentation, data entry, and reporting activities.

· Occasional lifting of up to 25 pounds may be required.

This position description is intended to convey information essential to understanding the scope of the role and is not an exhaustive list of skills, efforts, duties, responsibilities, or working conditions associated with it. Longeviti Neuro Solutions reserves the right to modify this position description at any time.