Quality Associate - Medical Devices

Job Description

Are you passionate about ensuring products meet the highest standards of safety, performance, and regulatory compliance? Join our team as a Quality Associate, where you'll play a key role in maintaining and improving our Quality Management System (QMS) in a fast paced medical device environment. You will work with a world leader in the development and manufacture of medical devices at Synapse Biomedical Inc. in Oberlin, OH. You will have the opportunity to contribute your skills on devices that significantly improve the lives of others, including Diaphragm Pacing, which has been developed in collaboration with Case Western Reserve University and the University Hospitals of Cleveland.

Our culture as a small company is best described by its people: smart, driven, energetic and committed to improve the lives of individuals with neurological impairment, such as spinal cord injury, stroke, respiratory deficiency and others.

About the Role

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.

What You'll Do

Primary 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

Secondary Responsibilities:

• 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

Bring Your Knowledge & Skills:

• 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

Experience & Education

• Minimum 2 years of experience in a quality role within a medical device company (3+ years preferred)

• High school diploma required

• Bachelor's degree in a scientific or technical discipline preferred

Tools & Technology

• Proficiency with Microsoft Office (Word, Excel, Outlook)

• Comfortable using computers, general office equipment, and basic laboratory/measuring tools

• Experience with quality management systems (QMS) or inventory management systems is a plus

Full-time