Accessvascular
Senior Quality Systems Engineer
Billerica, MA · Senior
Sponsorship not specified$93k-$160kDetected 57 days ago
Data AnalysisAuditingSystems EngineeringFDA RegulatoryMedical DevicesLeadershipMentoringWritingOrganizational Skills
About the role
- 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
- 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
- Collaborate with Operations to ensure manufacturing processes are controlled and validated
- Support incoming inspection, nonconforming material control, and disposition activities
- Provide Quality Engineering support to infrastructure move and expansion projects
Requirements
- Bachelor's degree in Engineering, Life Sciences, or a related technical field
- 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
- 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
- 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
- Prior experience at a startup or early-stage medical device company is a plus
Nice to have
- 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
Compensation
- Commensurate With Experience
- Access Vascular was founded in 2015 to address the most common and costly complications of intravenous therapy: infection, thrombosis and phlebitis.
- The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and have demonstrated 6X fewer complications..
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