Quality Assurance Specialist
About The 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.
Requirements
- Bachelor's or Master's degree in relevant field (science, engineering, technology, business, or similar).
- 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.
- 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.
- Attention to detail; self-starter; team-oriented mindset with the ability to contribute to and support shared goals in a small, collaborative team.
Nice To Haves
- 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.
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
