Quality Assurance Specialist

Job Description

Job Description

Summary of Position:  

The Quality Assurance Specialist ensures Vein360's Quality Management System (QMS) is effective, compliant, and continuously improving. This role partners with Operations, R&D, and Regulatory teams to maintain product quality, support new product development (including FDA 510(k) submissions), and improve internal processes — including the transition from paper-based systems to an electronic QMS (eQMS). Success in the first 12 months looks like a well-maintained, audit-ready QMS; measurable improvements in quality processes and operational efficiency; successful support of regulatory submissions and design control activities; and smooth adoption and optimization of the eQMS. 

This position is 100% on-site in Blue Ash, OH. Relocation assistance is not available for this role.

Essential Functions:  

• Actively supports day-to-day Quality Assurance operations, ensuring compliance with internal procedures and regulatory requirements. 

• Drives continuous improvement initiatives to increase efficiency, reduce costs, and strengthen compliance. 

• Enhances SOPs, work instructions, and QMS workflows, including supporting the transition to an electronic QMS (eQMS). 

• Conducts periodic QMS reviews and manages supplier quality activities. 

• Prepares and presents data for Management Reviews. 

• Ensures ongoing readiness for internal and external audits. 

• Leads and resolves quality events, including nonconformances (NCRs), investigations (INVs), and CAPAs. 

• Maintains quality documentation and employee training records. 

• Partners with R&D and Regulatory teams to contribute QA input to design controls and regulatory submissions (e.g., FDA 510(k)). 

• Leads projects and initiatives, and may mentor junior team members or interns. 

• Performs other duties as assigned. 

Minimum Requirements:  

Education: Bachelor's or Master's degree in relevant field (science, engineering, technology, business, or similar).

Experience : 5+ years of Quality Assurance experience in a regulated industry (e.g., medical devices, pharmaceuticals, aerospace, automotive, food, or clinical), including direct experience working in a manufacturing environment. 

Preferred Skills/Qualifications: ASQ certification(s) (e.g., CQE, CQA). Experience with medical device quality systems and regulations, including FDA Design Controls and/or ISO 13485. Proven experience leading or mentoring quality teams and/or interns. 

Skills/Competencies : Strong technical writing skills, including SOPs, work instructions, and controlled documentation. Hands-on experience managing quality data, including supplier- and customer-related information. Strong cross-functional collaboration skills, working effectively with Operations, R&D, and Regulatory teams. Ability to lead projects, initiatives, and/or junior team members. 

Other Skills: Attention to detail; self-starter; team-oriented mindset with the ability to contribute to and support shared goals in a small, collaborative team. 

Organizational Relationship / Scope:  

• Position reports to the Quality Manager or designee. 

• Part of a small Quality team that works closely and collaboratively together and with Operations and R team members provide backup and support to one another given the breadth of responsibility at a small company. 

• Interfaces regularly with Operations, R&D, and Regulatory. 

Working Conditions:  

Production, lab, and office environment. This job involves the reprocessing of medical devices and will include working with clinically used as well as cleaned medical devices in a controlled environment. Personal protective equipment (PPE) such as gowns, gloves, foot covers, and eye protection will be worn on a daily basis. 

Equal Employment Opportunity Statement  

Vein360 is an Equal Opportunity Employer. Employment decisions are based on business needs, job requirements, and individual qualifications. Vein360 does not discriminate on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other status protected by applicable federal, state, or local law. 

Vein360 is committed to providing reasonable accommodations to qualified individuals with disabilities in the application process and throughout employment, as required by applicable law. 

Disclaimer  

This job description and above statements are intended to describe the general nature and level of work performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, qualifications, or working conditions. Duties, responsibilities, and activities may change at any time, with or without notice, based on business needs.