Quality Associate - Mid-Level

Synapse Biomedical • Oberlin, OH

6h

About The Position

As a Quality Associate, you will support and lead key elements of our Quality Management System to ensure compliance with FDA, ISO 13485, and other global medical device regulations. You'll help ensure our products meet all requirements and specifications, support internal audits, and contribute to continuous quality improvement across the organization.

Requirements

• Familiarity with medical device regulations, including:
• FDA Quality System Regulation (21 CFR 820)
• ISO 13485
• Canadian Medical Device Regulations
• EU Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD)
• Ability to work effectively within a regulated quality system
• Strong communication and interpersonal skills
• Highly organized, detail‑oriented, and able to manage competing priorities
• Comfortable enforcing quality requirements under delivery schedule pressures
• Minimum 2 years of experience in a quality role within a medical device company (3+ years preferred)
• High school diploma required
• Proficiency with Microsoft Office (Word, Excel, Outlook)
• Comfortable using computers, general office equipment, and basic laboratory/measuring tools

Nice To Haves

• Bachelor's degree in a scientific or technical discipline preferred
• Experience with quality management systems (QMS) or inventory management systems is a plus

Responsibilities

• Lead and support subsystems of the Quality Management System (QMS)
• Participate in internal quality audits as an auditor
• Conduct quality activities including:
• Quality auditing
• Training coordination
• Nonconforming product management
• Supplier evaluation
• Incoming inspection
• Finished device acceptance
• Device history record review
• Quality system record maintenance
• Quality improvement initiatives
• Gather, analyze, and report quality data
• Ensure products are manufactured according to specifications and regulatory requirements
• Support document control processes
• Assist with complaint file management
• Participate in corrective and preventive action (CAPA) activities
• Support device tracking, labeling, and packaging control
• Assist with inspection, measuring, and test equipment processes

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED