Access Vascular
Medical Device
SeniorQualitySystemsEngineer
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“Senior Quality Systems Engineer at Access Vascular. Skills: Quality Management System, FDA 21 CFR Part 820, ISO 13485, ISO 14971. Manage QMS. Maintain QMS”
What You'll Achieve.
timely closure and effectiveness verification; inform continuous improvement; 6X fewer complications
Industry & Context.
root cause; effectiveness verification; risk-based decision making
What They're Looking For.
Must Have
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, 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
Nice to Have
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
What You'll Do.
Drive SOP improvement
Manage document control
Manage records management
Support external audits
Lead CAPA investigations
Develop quality metrics
Communicate quality data
Lead statistical methods development
Ensure manufacturing processes controlled
Ensure manufacturing processes validated
Support incoming inspection
Support nonconforming material control
Support disposition activities
Provide Quality Engineering support
Manage supplier qualification
Manage supplier evaluation
Manage supplier monitoring
Conduct supplier audits
Review supplier corrective action
Manage complaint handling
Manage trend analysis
Maintain knowledge of regulations
Communicate regulatory updates
Assist FDA inspections
Assist Notified Body audits
Champion quality culture
Provide quality training
Provide quality mentoring
How You'll Work.
Team & Collaboration
working among the AVI team; Collaborate with Operations; multidisciplinary team
Communication Scope
technical writing skills; communicate quality metrics; communicate updates to the team
Process & Methodology
infrastructure move and expansion projects
Full Job Description
Job Descriptions: 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. Responsibilities: 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 c
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