Quality Associate Mid-Level

Are you passionate about ensuring products meet the highest standards of safety performance and regulatory compliance Join our team as a Quality Associate where youll play a key role in maintaining and improving our Quality Management System (QMS) in a fastpaced medical device environment. You will work with a world leader in the development and manufacture of medical devices at Synapse Biomedical 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. Youll help ensure our products meet all requirements and specifications support internal audits and contribute to continuous quality improvement across the organization.

What Youll 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 detailoriented 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
Bachelors 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

Apply now and visit our website at

Required Experience:

Manager