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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior Quality Systems Engineer - **Company:** Access Vascular, Inc. - **Location:** Billerica, MA, United States - **Experience:** Expert - **Salary:** $93,000.0 - $160,000.0 - **Contract:** Permanent contract - **Skills:** Data Analysis, Data Integrity, Document Management Systems, Software Engineering - **Published:** May 27, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=6a0481ca0a71cae4 ## About the Role Do you have experience in Vendor compliance audits?, * Bachelor's degree in Engineering, Life Sciences, or a related technical field * Minimum of 5 years' of quality systems experience with a medical device manufacturing company * Proven track record with implementing, evolving, and improving medical device company quality management systems (QMS) compliant to FDA 21 CFR Part 820, ISO 13485:2016, and ISO 14971 * Demonstrated experience owning a QMS end-to-end, including CAPA, document control, complaints, internal auditing, and supplier quality * Strong technical writing skills with the ability to produce clear, compliant documentation * Experience with statistical techniques, sampling plans, and data analysis for validation and process capability * Highly organized, self-directed, and comfortable in a fast-paced environment * ASQ Certified Quality Engineer (CQE), Certified Medical Device Auditor (CMDA), or equivalent is a plus * Lead auditor certification (ISO 13485 or equivalent) is a plus * Experience with implementing and validating eQMS platforms (e.g., Greenlight Guru, MasterControl, ETQ) is a plus * Familiarity with IEC 62304 (software lifecycle) and IEC 60601 (electrical safety) is a plus * Experience supporting 510(k) submissions or technical files for CE marking is a plus * Prior experience at a startup or early-stage medical device company is a plus ## Description Manage the Access Vascular Inc (AVI) Quality Management System for a growing start-up company that designs, manufactures, and distributes sterile catheter-, software-, electromechanical-based medical device product families. Provide Quality Engineering support for Operations and Operations Quality projects and tasks. This is a key contributor position working closely among the AVI team with AVI's QMS and FDA QMSR requirements., Quality Management System * Own, maintain, and continuously improve the company's QMSR and ISO 13485-compliant QMS * Drive continuous improvement to company SOPs, work instructions, forms, test protocols, infrastructure software and other controlled documents * Manage document control and records management in compliance with 21 CFR Part 820 * Lead internal audits and support external audits (FDA, Supplier) * Lead CAPA investigations to root cause, ensuring timely closure and effectiveness verification * Develop and communicate quality metrics and data analysis to inform continuous improvement and risk-based decision making * Lead statistical methods development for quality metrics, inspection planning, and continuous improvement initiatives Operations & Supplier Quality * Collaborate with Operations to ensure manufacturing processes are controlled and validated * Act a subject matter expert (SME) for risk management, sterilization validation, and data integrity and how it defines validation, verification, and inspection sampling rigor * Support incoming inspection, nonconforming material control, and disposition activities * Provide Quality Engineering support to infrastructure move and expansion projects * Manage supplier qualification, evaluation, and monitoring programs * Conduct supplier audits and review supplier corrective action responses Post-Market Surveillance * Manage complaint handling, MDR reporting processes, and trend analysis * Maintain knowledge of applicable standards and regulations and communicate updates to the team * Assist in preparation for and response to FDA inspections and Notified Body audits Leadership & Culture * Champion a proactive quality culture across a small, multidisciplinary team * Provide quality training and mentoring to engineering, operations, and management staff ## Related Videos - [Data Science in Retail](https://www.wearedevelopers.com/videos/586-data-science-in-retail) - [Exploring 5 Key Applications of AI Abundance with Blockchain Assurance](https://www.wearedevelopers.com/videos/971-exploring-5-key-applications-of-ai-abundance-with-blockchain-assurance) - [The Avengers Initiative (Practical Ethics for Software Engineers)](https://www.wearedevelopers.com/videos/2070-the-avengers-initiative-practical-ethics-for-software-engineers) - [One Pipeline, Three Regulator - SBOM Compliance for the Developer](https://www.wearedevelopers.com/videos/100169-one-pipeline-three-regulator-sbom-compliance-for-the-developer) - [Valven Atlas: Engineering Intelligence That Delivers](https://www.wearedevelopers.com/videos/1660-valven-atlas-engineering-intelligence-that-delivers) - [Data Science on Software Data](https://www.wearedevelopers.com/videos/162-data-science-on-software-data) ## Related Articles - [Data Engineer Salary UK](https://www.wearedevelopers.com/magazine/253-data-engineer-salary-uk) - [Highest Paying Tech Companies for Developers](https://www.wearedevelopers.com/magazine/220-highest-paying-tech-companies-for-developers) - [Events like RSAC Get You CISOs. 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